Acupuncture Reduces Severity of Hot Flashes in Breast Cancer: A Randomized Single-Blind Trial.

This study evaluated the effectiveness of traditional Chinese medicine-based therapeutic acupuncture (TA) in reducing the severity of hot flashes (HFs) in breast cancer patients and compared the effectiveness of TA to "sham" placebo acupuncture (SA). Subjects experiencing more than 10 episodes of HF/week were randomly assigned to TA or SA. The response was assessed by the Menopause-specific Quality of Life (MenQoL) scale, scoring the subject's perception of the severity of HFs. HFs were scored at baseline, after treatment, and 1-month follow-up. A total of 54 subjects enrolled (28 TA and 26 SA). Seven women withdrew from the study. A hot flash diary documented the number of HFs a subject experienced. Analysis included 47 subjects (27 TA and 20 SA). A statistically significant response in HF scores was noted in the TA group compared with the SA group (P = .0064.) On average HF scores dropped by 1.89 with TA, and only 0.16 with SA. At follow-up, TA subjects had a sustained response. TA is effective in reducing the intensity and severity of HF. With SA, no relative response/change in HF scores was noted. Larger studies and longer follow-up to assess durability of response to TA are needed.

NCCN Guidelines® Insights: Distress Management, Version 2.2023.

These NCCN Guidelines for Distress Management discuss the identification and treatment of psychosocial problems in patients with cancer. All patients experience some level of distress associated with a cancer diagnosis and the effects of the disease and its treatment regardless of the stage of disease. Clinically significant levels of distress occur in a subset of patients, and identification and treatment of distress are of utmost importance. The NCCN Distress Management Panel meets at least annually to review comments from reviewers within their institutions, examine relevant new data from publications and abstracts, and reevaluate and update their recommendations. These NCCN Guidelines Insights describe updates to the NCCN Distress Thermometer (DT) and Problem List, and to the treatment algorithms for patients with trauma- and stressor-related disorders.

Distress Management, Version 3.2019, NCCN Clinical Practice Guidelines in Oncology.

Distress is defined in the NCCN Guidelines for Distress Management as a multifactorial, unpleasant experience of a psychologic (ie, cognitive, behavioral, emotional), social, spiritual, and/or physical nature that may interfere with the ability to cope effectively with cancer, its physical symptoms, and its treatment. Early evaluation and screening for distress leads to early and timely management of psychologic distress, which in turn improves medical management. The panel for the Distress Management Guidelines recently added a new principles section including guidance on implementation of standards of psychosocial care for patients with cancer.

Beneficial effects of animal-assisted visits on quality of life during multimodal radiation-chemotherapy regimens.

BACKGROUND: Animal-assisted visits (AAVs) are commonplace in cancer centers, but there is little evidence of their usefulness. OBJECTIVE: To test the efficacy of AAVs in improving the quality of life in patients with head and neck cancer receiving combined chemotherapy-radiation therapy. METHODS: 42 patients consented to daily AAVs during the time they received therapy for head and neck cancer. The Functional Assessment of Cancer Therapy-General Scale (FACT-G) was administered at baseline, week 3, and week 7 (at the end of therapy), and the Satisfaction With The AAV Intervention instrument, an 18-item scale adapted from the Pet Attitude Scale. RESULTS: 37 patients completed at least baseline and 1 follow-up assessment for a single group analysis of change over time. Means for Fact-G subscales showed significant declines in Physical Well-Being (PWB, P < .001) and Functional Well-Being (FWB, P = .003). In contrast, Social Well-Being increased (SWB, P = .03). Controlling for declines in PWB at each time point, increases in Emotional Well-Being (EWB) were also significant (P = .004). LIMITATIONS: Scheduling and patient preference prevented conducting a randomized trial. CONCLUSION: FACT-G analysis showed significant increase in SWB and EWB despite high symptom burden and clinically evident and expected declines in PWB and FWB. Mean scores for satisfaction related to psychological symptoms, liking animals/pets, and contact with animals were consistently higher than neutral score or Unsure (all, P < .001). Satisfaction related to physical symptoms was not significantly different from neutral. Though self-selected for an affinity to pets, patients endorsed a high level of satisfaction, which supports the usefulness of this intervention.

Effect of duloxetine on pain, function, and quality of life among patients with chemotherapy-induced painful peripheral neuropathy: a randomized clinical trial.

IMPORTANCE: There are no known effective treatments for painful chemotherapy-induced peripheral neuropathy. OBJECTIVE: To determine the effect of duloxetine, 60 mg daily, on average pain severity. DESIGN, SETTING, AND PATIENTS: Randomized, double-blind, placebo-controlled crossover trial at 8 National Cancer Institute (NCI)-funded cooperative research networks that enrolled 231 patients who were 25 years or older being treated at community and academic settings between April 2008 and March 2011. Study follow-up was completed July 2012. Stratified by chemotherapeutic drug and comorbid pain risk, patients were randomized to receive either duloxetine followed by placebo or placebo followed by duloxetine. Eligibility required that patients have grade 1 or higher sensory neuropathy according to the NCI Common Terminology Criteria for Adverse Events and at least 4 on a scale of 0 to 10, representing average chemotherapy-induced pain, after paclitaxel, other taxane, or oxaliplatin treatment. INTERVENTIONS: The initial treatment consisted of taking 1 capsule daily of either 30 mg of duloxetine or placebo for the first week and 2 capsules of either 30 mg of duloxetine or placebo daily for 4 additional weeks. MAIN OUTCOME MEASURES: The primary hypothesis was that duloxetine would be more effective than placebo in decreasing chemotherapy-induced peripheral neuropathic pain. Pain severity was assessed using the Brief Pain Inventory-Short Form "average pain" item with 0 representing no pain and 10 representing as bad as can be imagined. RESULTS: Individuals receiving duloxetine as their initial 5-week treatment reported a mean decrease in average pain of 1.06 (95% CI, 0.72-1.40) vs 0.34 (95% CI, 0.01-0.66) among those who received placebo (P = .003; effect size, 0.513). The observed mean difference in the average pain score between duloxetine and placebo was 0.73 (95% CI, 0.26-1.20). Fifty-nine percent of those initially receiving duloxetine vs 38% of those initially receiving placebo reported decreased pain of any amount. CONCLUSION AND RELEVANCE: Among patients with painful chemotherapy-induced peripheral neuropathy, the use of duloxetine compared with placebo for 5 weeks resulted in a greater reduction in pain. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00489411.

Distress management.

The integration of psychosocial care into the routine care of all patients with cancer is increasingly being recognized as the new standard of care. These NCCN Clinical Practice Guidelines in Oncology for Distress Management discuss the identification and treatment of psychosocial problems in patients with cancer. They are intended to assist oncology teams identify patients who require referral to psychosocial resources and to give oncology teams guidance on interventions for patients with mild distress to ensure that all patients with distress are recognized and treated.

Outcomes of guided imagery in patients receiving radiation therapy for breast cancer.

Guided imagery is an established intervention in integrative oncology. This study was initiated to evaluate the impact of guided imagery on patients undergoing radiation therapy for breast cancer. Eligible patients receiving guided imagery sessions were monitored via biofeedback before and after each session. Monitored measures included blood pressure, respiration rate, pulse rate, and skin temperature. In addition, the EuroQoL Group's EQ-5D questionnaire was used for subjective assessment and patient feedback was collected at the end of radiation therapy through a satisfaction survey. Measured parameters revealed statistically significant improvement from baseline, with decreases noted in respiration rate and pulse rate as well as systolic and diastolic blood pressure. Skin temperature increased, indicating more peripheral capillary flow secondary to a decrease in the sympathetic response. Overall, 86% of participants described the guided imagery sessions as helpful, and 100% said they would recommend the intervention to others. The results of this study illustrate the positive impact of guided imagery as measured through subjective and objective parameters. Improving the overall care for patients with breast cancer supports the value of incorporating practices of integrative oncology into standard practice.

Prevalence of Delayed Nausea and/or Vomiting in Patients Treated With Oxaliplatin-Based Regimens for Colorectal Cancer.

PURPOSE: To measure the prevalence of nausea and vomiting 2 to 5 days after oxaliplatin-based chemotherapy. PATIENTS AND METHODS: Sixty-four patients (55% men; 44% women) enrolled onto this cross-sectional study. Fifty-three (83%) had colon cancer and received oxaliplatin biweekly. Eleven (17%) had rectal cancer and received oxaliplatin weekly. We collected data on 23 patients for the first cycle and on 41 patients for the first two cycles, for a total of 105 cycles. Nausea and vomiting was graded using Common Toxicity Criteria. Patients maintained a 7-day postinfusion diary of nausea and vomiting and antiemetic use. RESULTS: All patients received antiemetics and steroids on day 1 of each cycle. For patients with data collected for both cycles, the occurrence of nausea was the same during cycles one and two. Thirty-nine percent used rescue antiemetics in cycle one, and 34% did so in cycle two. Sixty-eight percent of men reported no nausea in cycle one compared with 33% of women; for cycle two, these figures were 67% and 36%, respectively. Eighty-nine percent of patients reported no vomiting in cycle one, and 85% did so in cycle two. Seven patients (11%) had a history of motion sickness; 13 of 28 women (46%) reported history of pregnancy-induced morning sickness. Palonosetron slightly but significantly reduced the occurrence of nausea. Female sex and history of chemotherapy were significant risk factors for nausea. CONCLUSION: Delayed nausea associated with oxaliplatin was well controlled and evenly divided between grades 1 and 2; vomiting was rare. Factors associated with nausea were intrinsic to the patient and mostly unrelated to the antiemetics used. Sex and previous experience with emesis should be considered for efficient antiemetic management.

Medical oncologists' attitudes and practice in cancer pain management: a national survey.

PURPOSE: To evaluate the attitudes, knowledge, and practices of US medical oncologists that are related to management of cancer pain. METHODS: An anonymous survey was mailed to a geographically representative sample of medical oncologists randomly selected from the American Medical Association's Physician Master File. RESULTS: From a total of 2,000 oncologists, 354 responded to the original questionnaire and 256 responded to one of two subsequent shortened versions (overall response rate, 32%). Responders were demographically similar to all US medical oncologists. Using numeric rating scales of 0 to 10, oncologists rated their specialty highly for the ability to manage cancer pain (median, 7; interquartile range [IQR], 6 to 8) but rated their peers as more conservative prescribers than themselves (median, 3; IQR, 2 to 5). The quality of pain management training during medical school and residency was rated as 3 (IQR, 1 to 5) and 5 (IQR, 3 to 7), respectively. The most important barriers to pain management were poor assessment (median, 6; IQR, 4 to 7) and patient reluctance to take opioids (median, 6; IQR, 5 to 7) or report pain (median, 6; IQR, 4 to 7). Other barriers included physician reluctance to prescribe opioids (median, 5; IQR, 3 to 7) and perceived excessive regulation (median, 4; IQR, 2 to 7). In response to two vignettes describing challenging clinical scenarios, 60% and 87%, respectively, endorsed treatment decisions that would be considered unacceptable by pain specialists. Frequent referrals to pain or palliative care specialists were reported by only 14% and 16%, respectively. CONCLUSION: These data suggest that, for more than 20 years, a focus on cancer pain has not adequately addressed the perception of treatment barriers or limitations in pain-related knowledge and practice within the oncology community. Additional efforts are needed to achieve meaningful progress.

Impact of the Urban Zen Initiative on patients' experience of admission to an inpatient oncology floor: a mixed-methods analysis.

PURPOSE: The purpose of this study was to evaluate the impact of the Urban Zen Initiative, an "optimal healing environment" intervention, at Beth Israel Medical Center on both quantitative and qualitative measures of the experience of patients admitted for inpatient oncology care. MATERIALS AND METHODS: A quasi-experimental design was used comparing a baseline sample of patients admitted to the oncology floor before the intervention to a similar group admitted during the intervention. Data collected included the Profile of Mood States, the EuroQol-5D (EQ-5D), and, on a subset of patients, a semistructured qualitative interview. RESULTS: Patients in the intervention group experienced significantly less emotional distress during their stay when compared to patients in the baseline group. There were also significantly greater improvements in pain and discomfort during the stay in the treatment group as compared to controls. The qualitative analysis described a number of possible explanations for this change including increased sense of connection and control as well as specific techniques for symptom relief. CONCLUSIONS: It is possible to improve the experience of patients admitted for inpatient cancer care with a "healing environment" intervention. Further studies are needed that incorporate randomized design and the ability to examine specific components of the intervention independently as well as the impact of the intervention as a whole.

How bioethics can enrich medical-legal collaborations.

Medical-legal partnerships (MLPs) - collaborative endeavors between health care clinicians and lawyers to more effectively address issues impacting health care - have proliferated over the past decade. The goal of this interdisciplinary approach is to improve the health outcomes and quality of life of patients and families, recognizing the many non-medical influences on health care and thus the value of an interdisciplinary team to enhance health. This article examines the unique, interrelated ethical issues that confront the clinical and legal partners involved in MLPs. We contend that the ethical precepts of the clinical and legal professions should be seen as opportunities, not barriers, to further the interdisciplinary nature of MLPs. The commonalities in ethical approaches represent a potential bridge between legal and health care advocacy for patient/client well-being. Bioethics has a role to play in building and analyzing this bridge: bioethics may serve as a discourse and method to enhance collaboration by highlighting common ethical foundations and refocusing legal and clinical partners on their similar goals of service for patients/clients. This article explores this bridging role of bioethics, through a series of case studies. It concludes with recommendations to strengthen the collaborations.

Testosterone levels and quality of life in diverse male patients with cancers unrelated to androgens.

PURPOSE: Symptoms secondary to hormonal changes significantly impact quality of life (QoL) in patients with cancer. This cross-sectional study examines prevalence of hypogonadism and its correlation with QoL and sexual dysfunction. PATIENTS AND METHODS: We collected blood and medical histories from 428 male patients with non-testosterone-related cancer at three cancer centers. Serum was analyzed for total testosterone (TT), free testosterone (FT), bioavailable testosterone (BAT), and sex hormone binding globulin (SHBG). The Functional Assessment of Cancer Therapy-Prostate (FACT-P) QoL questionnaire measured physical, social, emotional, and functional domains as well as sexual function. Exclusion criteria were prostate, testicular, or male breast cancer; known hypogonadism; and HIV. RESULTS: Mean and median TTs were 337.46 and 310 ng/dL, respectively. The mean age of patients was 62.05 years. The crude prevalence of hypogonadism (ie, TT < 300 ng/dL) was 48%, and mean TT in hypogonadal patients was 176 ng/dL. The prevalences that were based on FT (ie, hypogonadal < 52 pg/dL) and BAT (ie, hypogonadal < 95 ng/dL) were 78% and 66%, respectively. The mean FT and BAT values in hypogonadal patients were 25 pg/dL and 45 ng/dL, respectively. Hypogonadal patients had decreased total QoL scores on FACT-P (P = .01) and decreased three-item sexual function subset (P = .003). CONCLUSION: The prevalence of hypogonadism was unexpectedly high. Measurement of FT or BAT detected a higher prevalence than TT alone, which confirmed previous studies. Correlation of T with FACT-P showed significant reduction of both overall QoL and sexual function for hypogonadal men. BAT and FT levels showed a stronger correlation than TT with overall FACT-P and subscales. The prevalence of symptomatic hypogonadism in male patients with cancer exceeds that found in comparable studies in noncancer populations.

Efficacy of dexmethylphenidate for the treatment of fatigue after cancer chemotherapy: a randomized clinical trial.

Cancer and its treatment can induce subjective and objective evidence of diminished functional capacity encompassing physical fatigue and cognitive impairment. Dexmethylphenidate (D-MPH; the D-isomer of methylphenidate) was evaluated for treatment of chemotherapy-related fatigue and cognitive impairment. A randomized, double-blind, placebo-controlled, parallel-group study evaluated the potential therapeutic effect and safety of D-MPH in the treatment of patients with chemotherapy-related fatigue. Change from baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue Subscale (FACIT-F) total score at Week 8 was the primary outcome measure. One hundred fifty-four patients (predominantly with breast and ovarian cancers) were randomized and treated. Compared with placebo, D-MPH-treated subjects demonstrated a significant improvement in fatigue symptoms at Week 8 in the FACIT-F (P=0.02) and the Clinical Global Impression-Severity scores (P=0.02), without clinically relevant changes in hemoglobin levels. Cognitive function was not significantly improved. There was a higher rate of study drug-related adverse events (AEs) (48 of 76 [63%] vs. 22 of 78 [28%]) and a higher discontinuation rate because of AEs (8 of 76 [11%] vs. 1 of 78 [1.3%]) in D-MPH-treated subjects compared with placebo-treated subjects. The most commonly reported AEs independent of study drug relationship in D-MPH-treated subjects were headache, nausea, and dry mouth, and in placebo-treated subjects were headache, diarrhea, and insomnia. D-MPH produced significant improvement in fatigue in subjects previously treated with cytotoxic chemotherapy. Further studies with D-MPH or other agents to explore treatment response in chemotherapy-associated fatigue should be considered.