Comprehensive Lifestyle Improvement Program for Prostate Cancer (CLIPP) is associated with improvement in weight and components of metabolic syndrome in men exposed to androgen deprivation therapy for prostate cancer.

BACKGROUND: Androgen deprivation therapy (ADT) for prostate cancer is associated with adverse effects, such as obesity and metabolic syndrome, which increase cardiovascular risk, the most common cause of non-cancer mortality in men diagnosed with prostate cancer. The Comprehensive Lifestyle Improvement Program for Prostate Cancer (CLIPP) was created to determine the feasibility of conducing a comprehensive lifestyle modification intervention in men on ADT for prostate cancer and determine its early efficacy in reducing obesity and metabolic syndrome. METHODS: A single-arm, open-label clinical trial was conducted by recruiting 31 men diagnosed with prostate cancer and exposed to ADT within the last 5 years. A multicomponent lifestyle modification program was delivered weekly for 16 weeks by a trained health coach. This was followed by 8 weeks of passive follow-up resulting in a total trial duration of 24 weeks. Feasibility was determined by calculating study recruitment, retention, and adherence rates. Weight and components of metabolic syndrome (waist circumference, triglycerides (TG), high-density lipoprotein (HDL), serum glucose, and blood pressure (BP)) were measured at baseline, 12, and 24 weeks. RESULTS: Recruitment, retention, and adherence rates were 47.1%, 90.3%, and 100%, respectively. Statistically significant improvements were noted between baseline and end of study measurements for weight (206.3 vs. 191.3 lbs, p < 0.001), waist (41.3 vs. 38.8 inches, p < 0.001), systolic BP (144.1 vs. 133.4 mm of Hg, p = 0.014), diastolic BP (83.3 vs. 76.2 mm of Hg, p = 0.0056), TG (146.0 vs. 113.8 mg/dl, p = 0.022), HDL (51.1 vs. 55.0 mg/dl, p = 0.012), and serum glucose (114.0 vs. 103.2 mg/dl, p = 0.013). CONCLUSION: CLIPP demonstrates feasibility and early efficacy of a multicomponent lifestyle modification intervention toward addressing obesity as well as components of metabolic syndrome in men on ADT for prostate cancer. This study provides strong preliminary data to develop future clinical trials in this population.

Protocol for a feasibility and early efficacy study of the Comprehensive Lifestyle Improvement Program for Prostate Cancer-2 (CLIPP2).

BACKGROUND: Although androgen deprivation therapy (ADT) for prostate cancer demonstrates improved overall and disease-free survival, it is associated with adverse effects such as obesity and metabolic syndrome that increase risk of cardiometabolic disease and diabetes type 2. ADT also leads to fatigue, depression and erectile dysfunction, which reduce quality of life (QoL). Lifestyle modification has shown promise in reducing obesity, metabolic syndrome and diabetes type 2 in other disease types. However, there is a paucity of data regarding the utility of lifestyle modification in men receiving ADT for prostate cancer. METHODS: The primary aim of the Comprehensive Lifestyle Improvement Program for Prostate Cancer-2 (CLIPP2) is to test the feasibility of conducting a 24-week lifestyle modification intervention in men on ADT for prostate cancer. Additionally, it will also determine the effect of this intervention on weight loss, cardiometabolic markers (secondary aim and markers of interest: serum glucose, insulin resistance, hemoglobin A1C and lipid panel), and QoL (tertiary aim). The intervention will be delivered weekly via telephone for the first 10 weeks and bi-weekly for the remaining 14 weeks. Questionnaires and serum samples will be collected at baseline, week 12, and week 24. Anthropometric measurements will be collected at baseline, week 6, week 12, week 18 and week 24. RESULTS: We hypothesize that the CLIPP2 intervention will produce a 7% weight loss that will result in improved markers associated with cardiometabolic disease and type 2 diabetes in the study population. CONCLUSION: Results will provide insight into the role of lifestyle modification in addressing ADT adverse effects as well as provide preliminary data to inform the development of future lifestyle interventions in this area. TRIAL REGISTRATION: NCT04228055 Clinicaltrials. gov.

Tai Chi and Qigong for cancer-related symptoms and quality of life: a systematic review and meta-analysis.

PURPOSE: This study aims to summarize and critically evaluate the effects of Tai Chi and Qigong (TCQ) mind-body exercises on symptoms and quality of life (QOL) in cancer survivors. METHODS: A systematic search in four electronic databases targeted randomized and non-randomized clinical studies evaluating TCQ for fatigue, sleep difficulty, depression, pain, and QOL in cancer patients, published through August 2016. Meta-analysis was used to estimate effect sizes (ES, Hedges' g) and publication bias for randomized controlled trials (RCTs). Methodological bias in RCTs was assessed. RESULTS: Our search identified 22 studies, including 15 RCTs that evaluated 1283 participants in total, 75% women. RCTs evaluated breast (n = 7), prostate (n = 2), lymphoma (n = 1), lung (n = 1), or combined (n = 4) cancers. RCT comparison groups included active intervention (n = 7), usual care (n = 5), or both (n = 3). Duration of TCQ training ranged from 3 to 12 weeks. Methodological bias was low in 12 studies and high in 3 studies. TCQ was associated with significant improvement in fatigue (ES = - 0.53, p < 0.001), sleep difficulty (ES = - 0.49, p = 0.018), depression (ES = - 0.27, p = 0.001), and overall QOL (ES = 0.33, p = 0.004); a statistically non-significant trend was observed for pain (ES = - 0.38, p = 0.136). Random effects models were used for meta-analysis based on Q test and I 2 criteria. Funnel plots suggest some degree of publication bias. Findings in non-randomized studies largely paralleled meta-analysis results. CONCLUSIONS: Larger and methodologically sound trials with longer follow-up periods and appropriate comparison groups are needed before definitive conclusions can be drawn, and cancer- and symptom-specific recommendations can be made. IMPLICATIONS FOR CANCER SURVIVORS: TCQ shows promise in addressing cancer-related symptoms and QOL in cancer survivors.

Drug withdrawal in women with progressive metastatic breast cancer while on aromatase inhibitor therapy.

BACKGROUND: Acquiring resistance to endocrine therapy is common in metastatic hormone-receptor-positive breast cancer (MBC). These patients most often transition either to next-line endocrine therapy or to systemic chemotherapy. However, withdrawal of endocrine therapy and observation as is selectively practiced in prostate cancer is another potential strategy for breast cancer patients. METHODS: A prospective, single-arm phase II trial of aromatase inhibitor (AI) withdrawal was performed in women with MBC, who had disease progression on AI therapy. The primary objective was to estimate the clinical benefit rate (defined as complete or partial response, or stable disease for at least 24 weeks, by RECIST criteria). Participants were monitored clinically and radiographically off all therapy at 8, 16 and 24 weeks after treatment and every 12 weeks thereafter until disease progression. RESULTS: Twenty-four patients (of 40 intended) were enrolled when the study was closed due to slow accrual. Clinical benefit rate overall was 46% (95% CI 26% to 67%). Median progression-free survival from time of AI withdrawal was 4 months. Two patients have remained progression free, off all treatment, for over 60 months. CONCLUSIONS: Despite suboptimal patient accrual, our results suggest that selected patients with metastatic breast cancer progressing on AI therapy can experience disease stabilisation and a period of observation after AI withdrawal. A randomised phase II trial is planned.

Panel reactive antibodies in women with ovarian cancer undergoing high-dose chemotherapy with peripheral stem cell rescue: a case control study.

High-dose chemotherapy with stem cell support is associated with a period of profound thrombocytopenia. During periods of thrombocytopenia, alloreactive antibodies can limit the effectiveness of platelet transfusion. In this institution, women undergoing high-dose chemotherapy with stem cell support for treatment of their ovarian cancer seemed to have a high incidence of panel reactive antibodies (PRA). To evaluate this further, a case-control study was performed comparing pretransplant PRA values in 22 consecutive women undergoing high-dose chemotherapy as intensification therapy for their ovarian cancer and a control group of 51 women receiving similar or identical therapy for their breast cancer. Parity was similar in both groups. Nonparametric t-test comparison of the two groups demonstrated a significantly higher PRA value in women with ovarian cancer compared to those with breast cancer (p = 0.032). Platelet transfusions were more common in women with ovarian cancer as compared to those with breast cancer (5.45/pt and 4.79/pt), although this difference did not reach statistical significance. This finding suggests that alloimmunization may be a more frequent problem in patients with ovarian cancer than in women with breast cancer.