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PURPOSE: Use qualitative and quantitative methods to explore factors influencing the adoption of guideline-based physical activity (PA) and dietary recommendations among participants enrolled in a lifestyle intervention during and after chemotherapy for breast cancer. METHODS: Among women with stage I-III breast cancer who participated in the intervention arm of the Lifestyle, Exercise, and Nutrition early after diagnosis (LEANer) trial, we used stratified, purposeful sampling to interview women who met both, one, or neither intervention goal after the 1-year intervention: (1) 150 min/week moderate-to-vigorous intensity exercise via a self-reported PA questionnaire and (2) improved self-reported diet quality measured by the Healthy Eating Index-2015. Semi-structured interviews were audio-recorded, transcribed verbatim, and analyzed using thematic content analysis. RESULTS: The 29 women interviewed were 52 ± 11 years old on average, with a mean body mass index of 29.6 ± 7.7 kg/m2. Three themes emerged regarding aspects of the LEANer intervention that facilitated behavior change: (1) providing a conduit of trustworthy, timely, and personalized support and education; (2) shifting mindsets and enhanced understanding of the benefits of PA and nutrition during chemotherapy; and (3) fostering a sense of control and alternative focus. Factors described as hindering adoption of goals included: (1) adverse effects of chemotherapy and (2) competing priorities. CONCLUSIONS: Women reported the external support, tailored education, and experiencing the physical and mental benefits of the LEANer intervention facilitated the adoption of the interventions' behavioral goals. Addressing chemotherapy-related symptoms and competing priorities may facilitate adherence to lifestyle interventions during chemotherapy for breast cancer.
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Neoplasias de la Mama , Ejercicio Físico , Humanos , Femenino , Neoplasias de la Mama/tratamiento farmacológico , Persona de Mediana Edad , Adulto , Anciano , Conductas Relacionadas con la Salud , Antineoplásicos/efectos adversos , Antineoplásicos/administración & dosificación , Antineoplásicos/uso terapéutico , Estilo de Vida , Investigación Cualitativa , Encuestas y CuestionariosRESUMEN
Chemotherapy treatment-related side-effects are common and increase the risk of suboptimal outcomes. Exercise interventions during cancer treatment improve self-reported physical functioning, fatigue, anxiety, and depression, but it is unclear whether these interventions improve important clinical outcomes, such as chemotherapy relative dose intensity (RDI). The National Cancer Institute funded the Exercise and Nutrition to Improve Cancer Treatment-Related Outcomes (ENICTO) Consortium, to address this knowledge gap. This paper describes the mechanisms hypothesized to underpin intervention effects on clinically-relevant treatment outcomes, briefly outlines each project's distinct research aims, summarizes the scope and organizational structure of ENICTO, and provides an overview of the integrated common data elements used to pursue research questions collectively. In addition, the paper includes a description of consortium-wide activities and broader research community opportunities for collaborative research. Findings from the ENICTO Consortium have the potential to accelerate a paradigm shift in oncology care such that cancer patients could receive exercise and nutrition programming as the standard of care in tandem with chemotherapy to improve RDI for a curative outcome.
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BACKGROUND: Hot flashes are a common side effect of endocrine therapy (ET) that contribute to poor quality of life and decreased treatment adherence. METHODS: Patients with breast cancer wo were receiving ET and experiencing hot flashes were enrolled through three parallel, randomized trials conducted in the United States, China, and South Korea. Participants were randomized to either immediate acupuncture (IA) or delayed acupuncture control (DAC). IA participants received 20 acupuncture sessions over 10 weeks, whereas DAC participants received usual care, then crossed over to acupuncture with a reduced intensity. The primary end point was a change in score on the endocrine symptom subscale of the Functional Assessment of Cancer Therapy (FACT)-Endocrine Symptoms between baseline and week 10. Secondary end points included the hot flash score and the FACT-Breast score. A planned pooled analysis of individual patient data was performed using longitudinal mixed models. RESULTS: In total, 158 women with stage 0-III breast cancer were randomized (United States, n = 78; China, n = 40; South Korea, n = 40). At week 10, IA participants reported statistically significant improvements in the endocrine symptom subscale score (mean change ± standard error: 5.1 ± 0.9 vs. 0.2 ± 1.0; p = .0003), the hot flash score (-5.3 ± 0.9 vs. -1.4 ± 0.9; p < .003), and the FACT-Breast total score (8.0 ± 1.6 vs. -0.01 ± 1.6; p = .0005) compared with DAC participants. The effect of the acupuncture intervention differed by site (p = .005). CONCLUSIONS: Acupuncture led to statistically and clinically meaningful improvements in hot flashes, endocrine symptoms, and breast cancer-specific quality of life in women undergoing ET for breast cancer in the United States, China, and South Korea.
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Terapia por Acupuntura , Neoplasias de la Mama , Sofocos , Calidad de Vida , Humanos , Femenino , Sofocos/terapia , Sofocos/inducido químicamente , Neoplasias de la Mama/terapia , Neoplasias de la Mama/complicaciones , Persona de Mediana Edad , Terapia por Acupuntura/métodos , Adulto , Anciano , República de Corea , Receptores de Estrógenos/metabolismo , Resultado del Tratamiento , China , Antineoplásicos Hormonales/efectos adversos , Antineoplásicos Hormonales/uso terapéutico , Estados UnidosRESUMEN
BACKGROUND: Physical activity and metformin pharmacotherapy are associated with improved clinical outcomes in breast and colorectal cancer survivors. Myokines are cytokines secreted from skeletal muscle that may mediate these associations. METHODS: This hypothesis-generating analysis used biospecimens collected from a multi-centre 2 × 2 factorial randomized design of 116 patients with stage I-III breast and colorectal cancer who were randomized to 12 weeks of (1) aerobic exercise (moderate intensity titrated to 220 min/week); (2) metformin (850 mg daily for 2 weeks and then titrated to 850 mg twice per day); (3) aerobic exercise and metformin; or (4) control. Fourteen myokines were quantified using a multiplex panel. Myokine concentrations were log-transformed, and main effects analyses were conducted using linear mixed-effects regression models. The type I error rate was controlled with the Holm sequential testing procedure. RESULTS: Randomization to exercise increased leukaemia inhibitory factor (1.26 pg/mL, 95% confidence interval [CI]: 0.69, 1.84; adjusted P = 0.001) and interleukin-15 (2.23 pg/mL, 95% CI: 0.87, 3.60; adjusted P = 0.013) compared with randomization to no exercise. Randomization to metformin decreased apelin (-2.69 pg/mL, 95% CI: -4.31, -1.07; adjusted P = 0.014) and interleukin-15 (-1.74 pg/mL, 95% CI: -2.79, -0.69; adjusted P = 0.013) compared with randomization to no metformin. Metformin decreased myostatin, irisin, oncostatin M, fibroblast growth factor 21 and osteocrin; however, these changes were not statistically significant after correction for multiple comparisons. CONCLUSIONS: This pilot study demonstrates that randomization to exercise and metformin elicit unique effects on myokine concentrations in cancer patients. This hypothesis-generating observation warrants further basic, translational and clinical investigation and replication.
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Neoplasias de la Mama , Neoplasias Colorrectales , Ejercicio Físico , Metformina , Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Neoplasias de la Mama/tratamiento farmacológico , Neoplasias Colorrectales/tratamiento farmacológico , Hipoglucemiantes/uso terapéutico , Hipoglucemiantes/farmacología , Metformina/uso terapéutico , Metformina/farmacología , Mioquinas/sangre , Mioquinas/metabolismoRESUMEN
PURPOSE: To update the ASCO guideline on the management of cancer-related fatigue (CRF) in adult survivors of cancer. METHODS: A multidisciplinary panel of medical oncology, geriatric oncology, internal medicine, psychology, psychiatry, exercise oncology, integrative medicine, behavioral oncology, nursing, and advocacy experts was convened. Guideline development involved a systematic literature review of randomized controlled trials (RCTs) published in 2013-2023. RESULTS: The evidence base consisted of 113 RCTs. Exercise, cognitive behavioral therapy (CBT), and mindfulness-based programs led to improvements in CRF both during and after the completion of cancer treatment. Tai chi, qigong, and American ginseng showed benefits during treatment, whereas yoga, acupressure, and moxibustion helped to manage CRF after completion of treatment. Use of other dietary supplements did not improve CRF during or after cancer treatment. In patients at the end of life, CBT and corticosteroids showed benefits. Certainty and quality of evidence were low to moderate for CRF management interventions. RECOMMENDATIONS: Clinicians should recommend exercise, CBT, mindfulness-based programs, and tai chi or qigong to reduce the severity of fatigue during cancer treatment. Psychoeducation and American ginseng may be recommended in adults undergoing cancer treatment. For survivors after completion of treatment, clinicians should recommend exercise, CBT, and mindfulness-based programs; in particular, CBT and mindfulness-based programs have shown efficacy for managing moderate to severe fatigue after treatment. Yoga, acupressure, and moxibustion may also be recommended. Patients at the end of life may be offered CBT and corticosteroids. Clinicians should not recommend L-carnitine, antidepressants, wakefulness agents, or routinely recommend psychostimulants to manage symptoms of CRF. There is insufficient evidence to make recommendations for or against other psychosocial, integrative, or pharmacological interventions for the management of fatigue.Additional information is available at www.asco.org/survivorship-guidelines.
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Supervivientes de Cáncer , Fatiga , Neoplasias , Humanos , Fatiga/etiología , Fatiga/terapia , Neoplasias/complicaciones , Neoplasias/terapia , Oncología Integrativa , Adulto , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
PURPOSE: To examine the prevalence and cancer-specific patterns of functional disabilities among US cancer survivors. METHODS: Data from 47,768 cancer survivors and 2,432,754 noncancer adults age 18 years and older from the 2017 to 2022 Behavioral Risk Factor Surveillance System were analyzed. Functional disabilities assessed included mobility disability (ie, serious difficulty walking or climbing stairs) and self-care disability (ie, self-reported difficulty dressing or bathing). Multivariable logistic regression models were used to assess the associations between functional disabilities and sociodemographic, lifestyle, and health-related factors. RESULTS: Cancer survivors tended to be older and non-Hispanic White than noncancer adults. The prevalence of mobility disability (27.9% v 13.4%) and self-care disability (7.4% v 3.8%) were higher among cancer survivors compared with noncancer adults. After multivariable adjustments, cancer survivors were more likely to report mobility (odds ratio [OR], 1.21 [95% CI, 1.16 to 1.26]) and self-care (OR, 1.19 [95% CI, 1.10 to 1.29]) disability than noncancer adults. The prevalence of mobility (34.9% v 26.3%) and self-care disability (9.8% v 6.7%) was higher in cancer survivors who were receiving active cancer treatment than in those who had completed cancer treatment. Higher prevalence of mobility and self-care disabilities was observed in cancer survivors who were racial/ethnic minorities and with higher BMI, low physical activity, lower levels of education and/or income, comorbidities, and those experiencing cancer/treatment-related pain. Patterns of mobility and self-care disabilities varied across cancer types. CONCLUSION: Over a quarter of US cancer survivors reported mobility disability, and nearly 10% reported self-care disability, with patterns varying across cancer types and treatment status. Racial/ethnic minorities, along with underserved groups and individuals with unhealthy lifestyles or comorbidities, were notably more affected by functional disabilities, underscoring the need for targeted disability prevention efforts.
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Supervivientes de Cáncer , Personas con Discapacidad , Limitación de la Movilidad , Neoplasias , Humanos , Supervivientes de Cáncer/estadística & datos numéricos , Masculino , Femenino , Persona de Mediana Edad , Prevalencia , Adulto , Anciano , Neoplasias/epidemiología , Estados Unidos/epidemiología , Personas con Discapacidad/estadística & datos numéricos , Adulto Joven , Adolescente , Autocuidado/estadística & datos numéricos , Actividades Cotidianas , Sistema de Vigilancia de Factor de Riesgo ConductualRESUMEN
BACKGROUND: Little is known about improving physical activity (PA) and diet during and after chemotherapy for breast cancer. This secondary analysis examines changes in PA and diet quality during a yearlong intervention for patients with breast cancer undergoing chemotherapy and evaluates factors associated with these changes. METHODS: Newly diagnosed patients with breast cancer (N = 173) undergoing chemotherapy were randomized to a year-long nutrition and exercise intervention (n = 87) or usual care (UC, n = 86). Mixed models compared 1-year changes in PA and diet quality via the Healthy Eating Index (HEI)-2015 by study arm. Among the intervention group, baseline factors associated with change in PA and diet were assessed with multivariable linear and logistic regression. RESULTS: At 1 year, compared with UC, the intervention arm increased PA more (mean difference = 136.1 minutes/week; 95% CI, 90.2-182.0), participated in more strength training (56% vs. 15%; p < .001), and had suggestive improvements in HEI-2015 (mean difference = 2.5; 95% CI, -0.3 to 5.3; p = .08). In the intervention arm, lower fatigue was associated with improved PA (p = .04) and higher education was associated with improved HEI-2015 (p = .001) at 1 year. Higher HEI-2015 (p = .04) and married/living with someone (p = .05) were associated with higher odds of participating in strength training at 1 year. CONCLUSIONS: This year-long lifestyle intervention for patients with breast cancer undergoing chemotherapy resulted in increases in PA and suggestive improvements in diet quality. Behavior change was associated with baseline fatigue, diet quality, education, and married/living with someone. Addressing these factors in interventions may improve uptake of lifestyle behaviors in trials during and after chemotherapy.
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Neoplasias de la Mama , Ejercicio Físico , Estilo de Vida , Humanos , Neoplasias de la Mama/tratamiento farmacológico , Femenino , Persona de Mediana Edad , Adulto , Anciano , Dieta Saludable , Estado Nutricional , DietaRESUMEN
BACKGROUND: N-terminal pro-brain natriuretic peptide (NT-proBNP) is a cardiac biomarker associated with the risk of heart failure and death in the general population, but it has not been explored in cancer survivors. METHODS: Using a US nationally representative sample of adults 20 years of age and older from the National Health and Nutrition Examination Survey from 1999 to 2004, this study compared NT-proBNP levels between adults without cancer (n = 12â574) and adult cancer survivors (n = 787). It examined the association of NT-proBNP with all-cause and cause-specific mortality among cancer survivors. RESULTS: Cancer survivors had higher NT-proBNP levels than adults without cancer (median [interquartile range] = 125.4 pg/mL [52.4-286.0] vs 43.2 pg/mL [20.3-95.0]). In particular, survivors of breast, prostate, and colorectal cancers had higher NT-proBNP levels than adults without cancer (multivariable-adjusted P < .05). In total, 471 survivors died (141 from cancer; 95 from cardiac disease) during a median follow-up period of 13.4 years (9393 person-years). Among cancer survivors, higher NT-proBNP levels were statistically associated with increased risks of all-cause death (hazard ratio [HR] = 1.31, 95% confidence interval [CI] = 1.18 to 1.46) and cardiac death (HR = 1.55, 95% CI = 1.21 to 2.00) but not with death from cancer (HR = 1.10, 95% CI = 0.92 to 1.32]). Higher NT-proBNP levels were associated with elevated overall mortality in survivors of prostate cancer (HR = 1.49, 95% CI = 1.22 to 1.81) and colorectal cancer (HR = 1.78, 95% CI = 1.00 to 3.16) (P = .169 for interaction). Nonlinear dose-response relationships were observed between NT-proBNP and mortality, with statistically significant relationships emerging above 125 pg/mL. CONCLUSIONS: Cancer survivors had higher NT-proBNP levels than adults without cancer, and elevated NT-proBNP levels were associated with higher risks of all-cause and cardiac mortality in cancer survivors.
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Supervivientes de Cáncer , Péptido Natriurético Encefálico , Neoplasias , Encuestas Nutricionales , Fragmentos de Péptidos , Humanos , Masculino , Péptido Natriurético Encefálico/sangre , Supervivientes de Cáncer/estadística & datos numéricos , Femenino , Fragmentos de Péptidos/sangre , Persona de Mediana Edad , Estados Unidos/epidemiología , Adulto , Neoplasias/mortalidad , Neoplasias/sangre , Anciano , Biomarcadores/sangre , Causas de Muerte , Insuficiencia Cardíaca/mortalidad , Insuficiencia Cardíaca/sangreRESUMEN
One in five women with breast cancer will relapse despite ideal treatment. Body weight and physical activity are strongly associated with recurrence risk, thus lifestyle modification is an attractive strategy to improve prognosis. Trials of dietary modification in breast cancer are promising but the role of specific diets is unclear, as is whether high-quality diet without weight loss can impact prognosis. Advanced glycation end-products (AGEs) are compounds produced in the body during sugar metabolism. Exogenous AGEs, such as those found in food, combined with endogenous AGEs, make up the total body AGE load. AGEs deposit in tissues over time impacting cell signaling pathways and altering protein functions. AGEs can be measured or estimated in the diet and measured in blood through their metabolites. Studies demonstrate an association between AGEs and breast cancer risk and prognosis. Here, we review the clinical data on dietary and serum AGEs in breast cancer.
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Neoplasias de la Mama , Productos Finales de Glicación Avanzada , Humanos , Femenino , Productos Finales de Glicación Avanzada/metabolismo , Productos Finales de Glicación Avanzada/uso terapéutico , Neoplasias de la Mama/tratamiento farmacológico , Reacción de Maillard , DietaRESUMEN
BACKGROUND: Diagnosis of breast cancer in young women has been shown to affect their decision-making with regard to fertility and family planning. Limited data are available from populations across the U.S. regarding this issue; thus, we sought to describe fertility concerns and efforts to preserve fertility in a national clinical trial population of young breast cancer patients. METHODS: The young and strong study was a cluster-randomized controlled trial testing an intervention program for young women with breast cancer. Patients were surveyed within 3 months after diagnosis and at 3, 6, and 12 months after. Surveys asked about sociodemographics, psychosocial domains, fertility concerns, and fertility preservation strategies. Univariable and multivariable models were used to investigate sociodemographic, clinical, and psychosocial predictors of fertility concerns. RESULTS: Of 467 women from 54 clinical sites across the U.S. (14 academic, 40 community), 419 were evaluable regarding fertility concerns. Median age was 40 years (range 22-45), 11% were Black, 6% Hispanic, and 75% had children. Tumor stage was I (35%), II (51%), or III (14%); 82% received chemotherapy. At time of the treatment decision, 133 (32%) participants had fertility concerns, among whom 47% indicated this affected their treatment decisions. Sixty percent of participants reported having discussed fertility with their physician. Twenty percent of those with fertility concerns used fertility preservation strategies. History of difficulty becoming pregnant and younger age were associated with higher odds of fertility concerns in multivariable modeling. CONCLUSION: Many young women with newly diagnosed breast cancer are concerned about fertility in a way that impacts their treatment decisions. Concerns were discussed, but few used fertility preservation strategies. These findings have implications for counseling young patients.
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Neoplasias de la Mama , Toma de Decisiones , Preservación de la Fertilidad , Humanos , Femenino , Neoplasias de la Mama/psicología , Neoplasias de la Mama/terapia , Adulto , Preservación de la Fertilidad/psicología , Preservación de la Fertilidad/métodos , Adulto Joven , Estados Unidos , Persona de Mediana Edad , Fertilidad , Encuestas y CuestionariosRESUMEN
OBJECTIVE: The purpose of this secondary analysis was to describe the prevalence of anxiety, depression, and perceived stress among women newly diagnosed with breast cancer and the impact of baseline and changes in anxiety on cognitive functioning following exercise and mind-body prehabilitation interventions. METHODS: The sample consisted of 49 women with newly diagnosed breast cancer (stages I-III) who planned to undergo breast cancer surgery at two academic cancer centers. Participants were randomized to receive an exercise or mind-body prehabilitation intervention between the time of diagnosis and breast cancer surgery. Participants completed self-report measures of anxiety, depression (HADS), perceived stress, and cognitive functioning (EORTC-QLQ-C30) at study enrollment and prior to surgery (post-intervention). The relationships between change in cognitive functioning and change in anxiety among all participants were estimated using linear regression modeling. RESULTS: A significant proportion of women with newly diagnosed breast cancer had clinically significant anxiety (34.0%). Greater anxiety was moderately associated with worse cognitive functioning (r = -0.33) at baseline. Linear modeling found that changes in cognitive functioning and anxiety were inversely related: Each one-unit decrease in anxiety was associated with a two-unit improvement in cognitive function (p = .06). CONCLUSIONS: Anxiety was common in women with newly diagnosed breast cancer and was related to worse cognitive functioning. Assessment of anxiety at the time of diagnosis may allow for earlier anxiety management and subsequent improvement in cognitive functioning.
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Importance: Physician turnover interrupts care delivery and creates health care system financial burden. Objective: To describe the prevalence of burnout, professional fulfillment, and intention to leave (ITL) among physicians at academic-affiliated health care systems and identify institutional and individual factors associated with ITL. Design, Setting, and Participants: This cross-sectional study administered a survey to 37 511 attending-level medical specialists at 15 academic medical institutions participating in the Healthcare Professional Well-Being Academic Consortium. Data were collected from October 2019 to July 2021. Statistical analysis was performed from May 2022 to March 2023. Exposures: Hypothesized institutional and individual determinants of occupational well-being. Main Outcomes and Measures: The main outcome was ITL, defined as having at least a moderate intention (a score of 2 on a 0-4 scale) to leave one's institution within the next 2 years. Additional outcomes included burnout and professional fulfillment, defined using published Professional Fulfillment Index cut points. Results: Of 18â¯719 academic physician survey respondents (8381 [44.8%] male; 2388 [12.8%] Asian, 10â¯599 [56.6%] White, 1039 [5.6%] other race, 4693 [25.1%] unknown race; 294 [1.6%] Hispanic or Latina/Latino/Latinx), 6903 of 18â¯217 (37.9%) met criteria for burnout and 7301 of 18â¯571 (39.3%) for professional fulfillment; 5177 of 15â¯890 (32.6%) reported moderate or greater ITL. Burnout, professional fulfillment, and ITL varied across specialties. After adjusting for demographics, each 1-point increase (range 0-10) in burnout was directly associated with ITL (odds ratio [OR], 1.52 [95% CI, 1.49-1.55])c, and each 1-point increase in professional fulfillment was inversely associated with ITL (OR, 0.64 [95% CI, 0.63-0.65]). After adjusting for demographics, burnout, and professional fulfillment, each 1-point increase (range 0-10) in supportive leadership behaviors (OR, 0.83 [95% CI, 0.82-0.84]), peer support (OR, 0.93 [95% CI, 0.91-0.95]), personal-organizational values alignment (OR, 0.81 [95% CI, 0.80-0.82]), perceived gratitude (OR, 0.95 [95% CI, 0.92-0.97]), COVID-19 organizational support (OR, 0.88 [95% CI, 0.85-0.91]), and electronic health record helpfulness (OR, 0.95 [95% CI, 0.93-0.97]) were inversely associated with ITL, whereas each 1-point increase (range 0-10) in depression (OR, 1.08 [95% CI, 1.05-1.10]) and negative impact of work on personal relationships (OR, 1.09 [1.07-1.11]) were directly associated with ITL. Conclusions and Relevance: In this cross-sectional study of academic physicians, 32.6% indicated moderate or higher ITL within 2 years. Burnout, lack of professional fulfillment, and other well-being factors were associated with ITL, suggesting the need for a comprehensive approach to reduce physician turnover.
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Agotamiento Profesional , Médicos , Humanos , Masculino , Femenino , Agotamiento Profesional/epidemiología , Estudios Transversales , Intención , Agotamiento PsicológicoRESUMEN
Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned coprimary or secondary analyses are not yet available. Clinical trial updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.Metformin has been associated with lower cancer risk in epidemiologic and preclinical research. In the MA.32 randomized adjuvant breast cancer trial, metformin (v placebo) did not affect invasive disease-free or overall survival. Here, we report metformin effects on the risk of new cancer. Between 2010 and 2013, 3,649 patients with breast cancer younger than 75 years without diabetes with high-risk T1-3, N0-3 M0 breast cancer (any estrogen receptor, progesterone receptor, human epidermal growth factor receptor 2) were randomly assigned to metformin 850 mg orally twice a day or placebo twice a day for 5 years. New primary invasive cancers (outside the ipsilateral breast) developing as a first event were identified. Time to events was described by the competing risks method; two-sided likelihood ratio tests adjusting for age, BMI, smoking, and alcohol intake were used to compare metformin versus placebo arms. A total of 184 patients developed new invasive cancers: 102 metformin and 82 placebo, hazard ratio (HR), 1.25; 95% CI, 0.94 to 1.68; P = .13. These included 48 contralateral invasive breast cancers (27 metformin v 21 placebo), HR, 1.29; 95% CI, 0.72 to 2.27; P = .40 and 136 new nonbreast primary cancers (75 metformin v 61 placebo), HR, 1.24; 95% CI, 0.88 to 1.74; P = .21. Metformin did not reduce the risk of new cancer development in these nondiabetic patients with breast cancer.
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Neoplasias de la Mama , Metformina , Femenino , Humanos , Neoplasias de la Mama/tratamiento farmacológico , Canadá/epidemiología , Método Doble Ciego , Metformina/uso terapéuticoRESUMEN
PURPOSE: Successful completion of chemotherapy is critical to improve breast cancer outcomes. Relative dose intensity (RDI), defined as the ratio of chemotherapy delivered to prescribed, is a measure of chemotherapy completion and is associated with cancer mortality. The effect of exercise and eating a healthy diet on RDI is unknown. We conducted a randomized trial of an exercise and nutrition intervention on RDI and pathologic complete response (pCR) in women diagnosed with breast cancer initiating chemotherapy. METHODS: One hundred seventy-three women with stage I-III breast cancer were randomly assigned to usual care (UC; n = 86) or a home-based exercise and nutrition intervention with counseling sessions delivered by oncology-certified registered dietitians (n = 87). Chemotherapy dose adjustments and delays and pCR were abstracted from electronic medical records. T-tests and chi-square tests were used to examine the effect of the intervention versus UC on RDI and pCR. RESULTS: Participants randomly assigned to intervention had greater improvements in exercise and diet quality compared with UC (P < .05). RDI was 92.9% ± 12.1% and 93.6% ± 11.1% for intervention and UC, respectively (P = .69); the proportion of patients in the intervention versus UC who achieved ≥85% RDI was 81% and 85%, respectively (P = .44). The proportion of patients who had at least one dose reduction and/or delay was 38% intervention and 36% UC (P = .80). Among 72 women who received neoadjuvant chemotherapy, women randomly assigned to intervention were more likely to have a pCR than those randomly assigned to UC (53% v 28%; P = .037). CONCLUSION: Although a diet and exercise intervention did not affect RDI, the intervention was associated with a higher pCR in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative and triple-negative breast cancer undergoing neoadjuvant chemotherapy.
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Neoplasias de la Mama , Neoplasias de la Mama Triple Negativas , Humanos , Femenino , Neoplasias de la Mama/tratamiento farmacológico , Ejercicio Físico/fisiología , Neoplasias de la Mama Triple Negativas/tratamiento farmacológico , Estado Nutricional , Dieta , Estilo de VidaRESUMEN
Importance: Chemotherapy-induced peripheral neuropathy (CIPN), one of the most common and severe adverse effects of chemotherapy, is associated with worse quality of life among survivors of ovarian cancer. Currently, there is no effective treatment for CIPN. Objective: To evaluate the effect of a 6-month aerobic exercise intervention vs attention-control on CIPN among women treated for ovarian cancer in the Women's Activity and Lifestyle Study in Connecticut (WALC) to provide evidence to inform the guidelines and recommendations for prevention or treatment of CIPN. Design, Setting, and Participants: This prespecified secondary analysis evaluated the Women's Activity and Lifestyle Study in Connecticut (WALC), a multicentered, open-label, population-based, phase 3 randomized clinical trial of an aerobic exercise intervention vs attention control for CIPN in patients who were diagnosed with ovarian cancer. Only WALC participants who received chemotherapy were included in this analysis. Participants were randomized 1:1 to either a 6-month aerobic exercise intervention or to attention control. All analyses were conducted between September 2022 and January 2023. Interventions: The exercise intervention consisted of home-based moderate-intensity aerobic exercise facilitated by weekly telephone counseling from an American College of Sports Medicine/American Cancer Society-certified cancer exercise trainer. Attention control involved weekly health education telephone calls from a WALC staff member. Main Outcomes and Measure: Change in CIPN was the primary outcome in this secondary analysis. This outcome was represented by CIPN severity, which was self-measured by participants at baseline and 6 months using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity scale, with a score range of 0 to 44. A mixed-effects model was used to assess the 6-month change in CIPN between the exercise intervention and attention control arms. Results: Of the 134 participants (all females; mean [SD] age, 57.5 [8.3] years) included in the analysis, 69 were in the exercise intervention arm and 65 were in the attention control arm. The mean (SD) time since diagnosis was 1.7 (1.0) years. The mean (SD) baseline CIPN scores were 8.1 (5.6) in the exercise intervention arm and 8.8 (7.9) in the attention control arm (P = .56). At 6 months, the self-reported CIPN score was reduced by 1.3 (95% CI, -2.3 to -0.2) points in the exercise intervention arm compared with an increase of 0.4 (95% CI, -0.8 to 1.5) points in the attention control arm. The between-group difference was -1.6 (95% CI, -3.1 to -0.2) points. The point estimate was larger among the 127 patients with CIPN symptoms at enrollment (-2.0; 95% CI, -3.6 to -0.5 points). Conclusions and Relevance: Findings of this secondary analysis of the WALC trial indicate that a 6-month aerobic exercise intervention vs attention control significantly improved self-reported CIPN among patients who were treated for ovarian cancer. While replication of the findings in other studies is warranted, incorporating referrals to exercise programs into standard oncology care could reduce CIPN symptoms and increase quality of life in patients with ovarian cancer. Trial Registration: ClinicalTrials.gov Identifier: NCT02107066.
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Antineoplásicos , Neoplasias Ováricas , Enfermedades del Sistema Nervioso Periférico , Estados Unidos , Humanos , Femenino , Persona de Mediana Edad , Calidad de Vida , Ejercicio Físico , Neoplasias Ováricas/tratamiento farmacológico , Enfermedades del Sistema Nervioso Periférico/inducido químicamente , Enfermedades del Sistema Nervioso Periférico/terapia , Antineoplásicos/efectos adversosRESUMEN
BACKGROUND: In randomized trials in women with breast cancer, exercise has been shown to have beneficial effects on cancer-related circulating biomarkers that may impact survival. Such studies are lacking for ovarian cancer. METHODS: This secondary analysis of a published randomized controlled trial examined the impact of a 6-month exercise intervention versus attention-control on change in prespecified circulating biomarkers (cancer antigen 125 (CA-125), C-reactive protein (CRP), insulin-like growth factor-1(IGF-1), insulin and leptin) in a subset of participants who provided a fasting blood draw (N = 104/144) at enrollment and at 6 months. Change in biomarkers between study arms was compared using a linear mixed effects model analysis. An exploratory analysis of the exercise intervention versus attention-control on all-cause mortality included all (N = 144) participants. All statistical tests were two-sided. RESULTS: Participants included in the biomarker analysis were 57.0 ± 8.8 (mean ± SD) years old and 1.6 ± 0.9 years post-diagnosis. Adherence to the exercise intervention was 176.4 ± 63.5 min/week. Post intervention IGF-1 (group difference in change: -14.2 (-26.1 to -2.3) ng/mL (least squared means (95% CI))) and leptin (-8.9 (-16.5 to -1.4) ng/mL) were significantly reduced in the exercise group (N = 53) compared to those in attention-control (N = 51). No group difference in change was seen for CA-125 (p = 0.54), CRP (p = 0.95), or insulin (p = 0.37). With median follow-up of 70 months [range 6.6-105.4 months], 50/144 (34.7%) (exercise group; 24/74 (32.4%) versus attention-control group; 26/70 (37.1%)) participants died with no between group difference in overall survival (p = 0.99). CONCLUSIONS: Further studies are needed to determine the clinical significance of exercise-induced changes in cancer-related circulating biomarkers in women with ovarian cancer.
Asunto(s)
Neoplasias de la Mama , Neoplasias Ováricas , Humanos , Femenino , Biomarcadores de Tumor , Factor I del Crecimiento Similar a la Insulina , Leptina , Biomarcadores , Proteína C-Reactiva/análisis , Neoplasias Ováricas/terapia , Insulina/metabolismoRESUMEN
BACKGROUND: The MA32 study investigated whether 5 years of metformin (versus placebo) improves invasive disease-free survival in early-stage breast cancer (BC). Non-adherence to endocrine therapy (ET) and medications for chronic conditions is common and increases with drug toxicity and polypharmacy. This secondary analysis evaluates rates and predictors of early discontinuation of metformin, placebo, and ET among participants with HR-positive BC. METHODS: Patients with high-risk non-metastatic BC were randomized to 60 months of metformin (850 mg BID) or placebo BID. Patients were administered bottles of metformin/placebo every 180 days. Metformin/placebo adherence was defined as a bottle dispensed at month 48 or later. The ET adherence analysis included patients with HR-positive BC who received ET with start and stop date reported, with adherence defined as > 48 months of use. Associations of covariates with study drug and ET adherence were examined using multivariable models. RESULTS: Among the 2521 HR-positive BC patients, 32.9% were non-adherent to study drug. Non-adherence was higher among patients on metformin vs placebo (37.1% vs 28.7%, p < 0.001). Reassuringly, ET discontinuation rates were similar between treatment arms (28.4% vs 28.0%, p = 0.86). Patients who were non-adherent to ET were more likely to discontinue study therapy (38.8% vs 30.1%, p < 0.0001). In a multivariable analysis, study drug non-adherence was increased with metformin vs placebo (OR: 1.50, 95% CI 1.25-1.80; p < 0.0001); non-adherence to ET (OR: 1.47, 95% CI 1.20-1.79, p < 0.0001); grade 1 or greater GI toxicity during the first 2 years; lower age; and higher body mass index. CONCLUSION: While non-adherence was higher among patients on metformin, it was still considerable among patients on placebo. Reassuringly, treatment arm allocation did not impact ET adherence. Attention to global medication adherence is needed to improve BC and non-oncological outcomes in cancer survivors. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01.
Asunto(s)
Neoplasias de la Mama , Metformina , Humanos , Femenino , Neoplasias de la Mama/patología , Metformina/efectos adversos , Supervivencia sin Enfermedad , Método Doble Ciego , Supervivencia sin ProgresiónRESUMEN
BACKGROUND: Obesity and inactivity are poor prognostic factors in breast cancer, but less is known regarding physical activity (PA) and weight patterns in young breast cancer survivors. METHODS: The Young and Strong Study was a cluster-randomized trial evaluating education and support interventions for young women (age <45 years) with newly diagnosed breast cancer. Sites were randomized 1:1 to a Young Women's Intervention (YWI) or a contact-time control physical activity intervention (PAI). Changes in PA and weight were compared between groups using general estimating equations to evaluate clustered binary and Gaussian data. RESULTS: A total of 467 patients enrolled between July 2012 and December 2013 across 54 sites. Median age at diagnosis was 40 years (range, 22-45). At baseline, median body mass index (BMI) was 25.4 kg/m2 (range, 16.1-61.1), and participants reported a median of 0 minutes (range, 0-2190) of moderate/vigorous PA/week. PA increased significantly over time in both groups (p < .001), with no difference between groups at any time point. BMI increased modestly but significantly (p < .001) over time in both groups. Provider attention to PA was observed in 74% of participants on PAI and 61% on YWI (p = .145) and correlated with PA at 12 months (median 100 min/week of PA in participants with provider attention to PA vs. 60 min/week in those without, p = .016). CONCLUSIONS: In a cohort of young women with breast cancer, rates of obesity and inactivity were high. PA and BMI increased over time and were not impacted by an educational PA intervention. Findings provide important information for developing lifestyle interventions for young breast cancer survivors.
Asunto(s)
Neoplasias de la Mama , Humanos , Femenino , Adulto Joven , Adulto , Persona de Mediana Edad , Neoplasias de la Mama/terapia , Neoplasias de la Mama/diagnóstico , Ejercicio Físico , Estilo de Vida , Obesidad/terapia , Índice de Masa CorporalRESUMEN
OBJECTIVE: Following the outbreak of COVID-19, access to in-person oncology acupuncture service was temporarily disrupted at Dana-Farber Cancer Institute, a National Cancer Institute (NCI)-designated cancer center. During this period, a virtual acupuncturist-guided session of patient self-acupressure was implemented to provide continuity of supportive care for cancer patients. We provide preliminary findings on the feasibility and potential impact of remotely delivered acupressure on patient-reported symptom burden in cancer populations. METHODS: This is a retrospective chart review of cancer patients who received virtual acupressure service at a single academic cancer center from May 11 to December 31, 2020. Each telehealth session consisted of a one-on-one appointment between the patient and acupuncturist. A semi-standardized set of acupoints were used, including Yintang, ST36, GB20, PC6, and HT7 as well as Relaxation Point on the ear. At the start of each session, Edmonton Symptom Assessment System (ESAS) was used to collect patient-reported symptom burden. For patients with at least one follow-up within 14 days of the baseline visit, paired t-test was used to analyze changes in ESAS scores from baseline to first follow-up. RESULTS: A total of 102 virtual acupressure sessions were administered to 32 patients. Most patients were females (90.6%) and white (84.4%), and the mean age was 55.7 (range = 26-82; SD = 15.7). The most common cancer diagnosis was breast (53.1%), followed by pancreatic (12.5%) and lung (9.4%). Baseline ESAS Total, Physical, and Emotional scores were 21.5 (SD = 11.1), 12.4 (SD = 7.5), and 5.2 (SD = 3.8), respectively. Of 32 patients, 13 (41%) had a second acupressure session within 14 days. For these 13 patients, there was a statistically significant reduction in Total symptom burden (-4.9 ± 7.6; p = 0.04) and in Physical (-3.5 ± 5.4; p = 0.04) and Emotional (-1.2 ± 1.8; p = 0.03) subscales from baseline to follow-up. CONCLUSION: Virtual acupressure was associated with significant reduction in symptom burden among cancer patients from their baseline to follow-up visits. Larger scale randomized clinical studies are needed to confirm these findings and better understand the impact of virtual acupressure on symptom burden in cancer populations.