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1.
Integr Cancer Ther ; 22: 15347354221148710, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-36680352

RESUMEN

BACKGROUND: We explored the use of a novel smart phone-based application (APP) for delivery and monitoring of meditation to treat mood symptoms experienced by cancer patients. METHODS: We assessed the feasibility of using a meditation delivery and tracking APP over 2-weeks and its impact on cancer patients' self-reported anxiety and depression. Outpatients reporting depression and/or anxiety were recruited and randomized to the APP or waitlist control group. Assessments included an expectancy scale, exit survey, mood rating before and after each meditation, and the Edmonton Symptom Assessment Scale (ESAS-FS), Hospital Anxiety and Depression Scale (HADS), and Pittsburgh Sleep Quality Index (PSQI) at baseline and after 2-weeks. The primary aim was to assess feasibility; secondary aims included satisfaction with the APP, association between meditation frequency and length with self-reported symptoms, and change in symptom measures (symptoms, anxiety, depression, and sleep). RESULTS: Our study included 35 participants (17 meditation group; 18 controls) who were primarily female (94%) with breast cancer (60%). The 61% enrollment rate and 71% adherence rate met pre-specified feasibility criteria. Most meditation group participants described the APP as "Useful" to "Very Useful" and would "Probably" or "Definitely" recommend its use. Mixed model analysis revealed a statistically significant association between meditation length (5, 10, or 15 minutes) and change in anxiety, with 15-minute sessions associated with greater reductions in anxiety. In the exit survey, more meditation group vs. control group participants reported improved focus, mood, and sleep. Study groups differed significantly by ESAS fatigue score change; the meditation group decreased a median of 1.5 pts (IQR 2.5) and the control group increased a median of 0.5 points (IQR 2). The meditation group, but not the control group, experienced statistically significant improvement in ESAS fatigue, depression, anxiety, appetite, and physical, psychological, and global distress. Change in PSQI and HADS anxiety and depression scores did not reveal any statistically significant between-group differences. CONCLUSIONS: This pilot study demonstrated the feasibility and acceptability of a meditation APP for cancer patients. Meditation APP users reported improvement in several measures of symptom distress. Future studies should explore ways to enhance the APP's usability and clinical benefit.


Asunto(s)
Neoplasias de la Mama , Meditación , Humanos , Femenino , Meditación/psicología , Proyectos Piloto , Depresión/terapia , Depresión/psicología , Fatiga/terapia
2.
Invest New Drugs ; 39(4): 1113-1122, 2021 08.
Artículo en Inglés | MEDLINE | ID: mdl-33580845

RESUMEN

Purpose Acute radiation-induced esophagitis (ARIE) leads to treatment delays, decreased quality of life (QOL), and secondary adverse events such as weight loss. Grade 3 ARIE occurs in 15%-30% of patients undergoing radiotherapy to the esophagus, leading to disruption or discontinuation of treatment. The purpose of this study was to assess the effects of glutamine, a common nutritional supplement, on ARIE in patients with thoracic malignancies. Patients and methods This double-blind, placebo-controlled trial enrolled patients with advanced thoracic malignancies receiving concurrent chemotherapy/radiotherapy or radiotherapy alone, with radiation doses to the esophagus ≥45 Gy. Patients were randomized (1:1) to receive 4 g of glutamine or glycine placebo twice daily. The primary objective was to determine whether glutamine decreases the severity of ARIE in these patients. Secondary objectives included assessment of the effects of glutamine on other measures of ARIE, weight, symptom burden measure assessed by the MD Anderson Symptom Inventory (MDASI-HN) questionnaire and the toxicity profile of glutamine. Results At the time of interim analysis, 53 patients were enrolled: 27 in the glutamine arm and 26 in the placebo arm. There was no difference in the incidence of esophagitis in the first 6 weeks of radiotherapy between the glutamine and placebo arms (74% versus 68%; P = 1.00). There were no significant differences between the two arms for time to onset of esophagitis. The duration of ARIE was shorter (6.3 versus 7.1 weeks; P = 0.54) and median weight loss was lower (0.9 kg versus 2.8 kg; p = 0.83) in the glutamine arm versus the placebo arm. The groups differ significantly in core symptom severity (2.1 vs 1.5, p < .03) but not in head and neck specific symptom severity (1.2 vs 1.1, p < .60) nor in symptom interference (2.1 vs 1.7, p < .22). There was no grade 3 or higher adverse event at least possibly related to glutamine. The study was terminated for futility following interim analysis. Conclusion Oral glutamine was not associated with significant improvement in severity of ARIE, weight loss, head and neck specific symptoms or symptom interference compared with placebo in patients with advanced thoracic malignancies receiving radiotherapy to the esophagus.Clinical trial information. NCT01952847, and date of registration is September 30, 2013.


Asunto(s)
Esofagitis/prevención & control , Glutamina/administración & dosificación , Traumatismos por Radiación/prevención & control , Neoplasias Torácicas/radioterapia , Anciano , Antineoplásicos/administración & dosificación , Terapia Combinada , Método Doble Ciego , Esofagitis/epidemiología , Esofagitis/etiología , Femenino , Glutamina/efectos adversos , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Traumatismos por Radiación/epidemiología , Índice de Severidad de la Enfermedad , Factores de Tiempo
3.
PLoS One ; 15(7): e0235461, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-32649717

RESUMEN

OBJECTIVE: Intranasal fentanyl (INF) quickly and noninvasively relieves severe pain, whereas intravenous hydromorphone (IVH) reliably treats severe cancer pain but requires vascular access. The trial evaluated the efficacy of INF relative to IVH for treating cancer patients with severe pain in an emergency department (ED) setting. METHODS: We randomized 82 patients from a comprehensive cancer center ED to receive INF (n = 42) or IVH (n = 40). Eligible patients reported severe pain at randomization (≥7, scale: 0 "none" to 10 "worst pain"). We conducted non-inferiority comparisons (non-inferiority margin = 0.9) of pain change from treatment initiation (T0) to one hour later (T60). T0 pain ratings were unavailable; therefore, we estimated T0 pain by comparing 1) T60 ratings, assuming similar group T0 ratings; 2) pain change, estimating T0 pain = randomization ratings, and 3) pain change, with T0 pain = 10 (IVH group) or T0 pain = randomization rating (INF group). RESULTS: At T60, the upper 90% confidence limit (CL) of the mean log-transformed pain ratings for the INF group exceeded the mean IVH group rating by 0.16 points (>pain). Substituting randomization ratings for T0 pain, the lower 90% CL of mean pain change in the INF group extended 0.32 points below (

Asunto(s)
Analgésicos Opioides/administración & dosificación , Dolor en Cáncer/tratamiento farmacológico , Fentanilo/administración & dosificación , Neoplasias/tratamiento farmacológico , Administración Intranasal , Administración Intravenosa , Adulto , Anciano , Analgésicos Opioides/efectos adversos , Dolor en Cáncer/complicaciones , Dolor en Cáncer/patología , Servicio de Urgencia en Hospital , Femenino , Fentanilo/efectos adversos , Humanos , Masculino , Persona de Mediana Edad , Neoplasias/complicaciones , Neoplasias/patología
4.
J Pediatr Surg ; 51(12): 2063-2067, 2016 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-27686483

RESUMEN

PURPOSE: The purpose of this study was to evaluate the impact of hospital specialization on survival in pediatric melanoma. METHODS: We reviewed all patients under 18years old with cutaneous melanoma evaluated at MD Anderson Cancer Center, a National Cancer Institute (NCI)-designated center, from 2000 to 2014. We compared overall survival (OS) and disease-free survival (DFS) between patients who underwent all treatments at MDACC (Group A, n=146) and those who underwent initial surgical treatment at a non-NCI center (Group B, n=58). Kaplan-Meier survival curves were compared using the log-rank test. RESULTS: Group A patients had significantly better OS and DFS (both p<0.001). Five-year OS was 97% (95% CI 92%-99%) in Group A versus 88% (95% CI 74%-94%) in Group B. Group survival differences were most notable in Stage 3 and 4 patients. Group A patients presenting with stage III or IV disease had a 5-year OS rate of 91.2% (95% CI 75.1%-97.1%) compared to 80.8% (95% CI 59.8%-91.5%) in Group B. The DFS rate was 94.4% (95% CI 88.5%-97.3%) in Group A versus 77.2% (95% CI 62.5%-86.7%) in Group B. CONCLUSION: Surgical treatment at a comprehensive cancer center may improve outcomes for pediatric melanoma especially for patients presenting with later stage disease. LEVEL OF EVIDENCE: Case-control study: Level III.


Asunto(s)
Melanoma/terapia , Estadificación de Neoplasias , Adolescente , Niño , Preescolar , Terapia Combinada , Supervivencia sin Enfermedad , Femenino , Humanos , Lactante , Estimación de Kaplan-Meier , Masculino , Melanoma/diagnóstico , Melanoma/mortalidad , Neoplasias Cutáneas , Tasa de Supervivencia/tendencias , Texas/epidemiología , Resultado del Tratamiento
5.
BMC Cancer ; 15: 304, 2015 Apr 18.
Artículo en Inglés | MEDLINE | ID: mdl-25900027

RESUMEN

BACKGROUND: Angiogenesis plays a role in tumor growth and is partly mediated by factors in both the fibroblast growth factor (FGF) and vascular endothelial growth factor (VEGF) pathways. Durable clinical responses with VEGF tyrosine kinase inhibitors (TKIs) may be limited by intrinsic tumor resistance. We hypothesized that FGF signaling may impact clinical responses to sorafenib. METHODS: Nephrectomy material was available from 40 patients with metastatic renal cell carcinoma (RCC) enrolled in a phase II clinical trial of sorafenib ± interferon (ClinicalTrials.gov Identifier NCT00126594). Fibroblast growth factor receptor 1 (FGFR1) and fibroblast growth factor receptor substrate 2 alpha (FRS2α) expression was assessed by in situ hybridization and immunofluorescence, respectively. The relationship between fibroblast growth factor pathway marker levels and progression-free survival (PFS) was analyzed using Kaplan-Meier and Cox proportional hazards regression methods. RESULTS: Univariate analysis indicated that more intense FGFR1 staining was associated with shorter PFS (log-rank P = 0.0452), but FRS2α staining was not significantly associated with PFS (log-rank P = 0.2610). Multivariate Cox proportional hazards regression models were constructed for FGFR1 and FRS2α individually, adjusting for baseline Eastern Cooperative Oncology Group performance status, treatment arm and anemia status. When adjusted for each of these variables, the highest intensity level of FGFR1 (level 3 or 4) had increased progression risk relative to the lowest intensity level of FGFR1 (level 1) (P = 0.0115). The highest intensity level of FRS2α (level 3 or 4) had increased progression risk relative to the lowest intensity level of FRS2α (level 1) (P = 0.0126). CONCLUSIONS: Increased expression of FGFR1 and FRS2α was associated with decreased PFS among patients with metastatic RCC treated with sorafenib. The results suggest that FGF pathway activation may impact intrinsic resistance to VEGF receptor inhibition.


Asunto(s)
Proteínas Adaptadoras Transductoras de Señales/biosíntesis , Antineoplásicos/uso terapéutico , Carcinoma de Células Renales/metabolismo , Regulación Neoplásica de la Expresión Génica , Proteínas de la Membrana/biosíntesis , Niacinamida/análogos & derivados , Compuestos de Fenilurea/uso terapéutico , Receptor Tipo 1 de Factor de Crecimiento de Fibroblastos/biosíntesis , Anciano , Anciano de 80 o más Años , Carcinoma de Células Renales/diagnóstico , Carcinoma de Células Renales/tratamiento farmacológico , Femenino , Humanos , Masculino , Persona de Mediana Edad , Niacinamida/uso terapéutico , Estudios Prospectivos , Sorafenib , Resultado del Tratamiento
6.
Cancer ; 116(1): 57-65, 2010 Jan 01.
Artículo en Inglés | MEDLINE | ID: mdl-19862815

RESUMEN

BACKGROUND: The objective of this study was to independently evaluate the objective response rate of sorafenib and sorafenib plus low-dose interferon-alfa 2b (IFN) as frontline therapy in patients with metastatic renal cell carcinoma (mRCC). METHODS: Untreated patients with clear cell mRCC were randomized to receive sorafenib 400 mg orally twice daily or sorafenib 400 mg orally twice daily plus subcutaneous IFN 0.5 million U (MU) twice daily. Primary endpoints included the objective response rate (ORR) and safety. Secondary endpoints included progression-free survival (PFS) and overall survival (OS). Exploratory endpoints included the predictive value of tumor tissue biomarkers. RESULTS: Eighty patients were enrolled. The median follow-up was 19.7 months (range, 0-34.2 months). The ORR was 30% (95% confidence interval [CI], 16.6%-46.5%) in the sorafenib arm and 25% (95% CI, 12.7%-41.2%) in the combination arm. The median PFS was 7.39 months in the sorafenib-alone arm (95% CI, 5.52-9.20 months) and 7.56 months in the sorafenib plus IFN arm (95% CI, 5.19-11.07 months). The median OS was 27.04 months in the combination arm (95% CI, from 22.31 to not attained) and was not reached in the sorafenib arm. Toxicities were comparable in both arms. In a multivariate model, increased phosphorylated protein kinase B (pAKT) levels were associated with poorer PFS (hazard ratio, 1.04; 95% CI, 1.00-1.08; P = .0411) and OS (hazard ratio, 1.15; 95% CI, 1.02-1.29; P = .0173). CONCLUSIONS: The addition of low-dose IFN to sorafenib resulted in efficacy outcomes that were comparable to those achieved with sorafenib monotherapy. The current results indicated that pAKT levels may predict for clinical outcome, but further mechanistic study is required.


Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Bencenosulfonatos/administración & dosificación , Carcinoma de Células Renales/tratamiento farmacológico , Interferón-alfa/administración & dosificación , Neoplasias Renales/tratamiento farmacológico , Piridinas/administración & dosificación , Anciano , Anciano de 80 o más Años , Biomarcadores de Tumor/análisis , Supervivencia sin Enfermedad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Niacinamida/análogos & derivados , Compuestos de Fenilurea , Sorafenib
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