Weight loss for overweight and obese patients with prostate cancer: A study protocol of a randomised trial comparing clinic-based versus telehealth delivered exercise and nutrition intervention (the TelEX trial)

Introduction Obese men with prostate cancer have an increased risk of biochemical recurrence, metastatic disease and mortality. For those undergoing androgen deprivation therapy (ADT), substantial increases in fat mass are observed in the first year of treatment. Recently, we showed that a targeted supervised clinic-based exercise and nutrition intervention can result in a substantial reduction in fat mass with muscle mass preserved in ADT-treated patients. However, the intervention needs to be accessible to all patients and not just those who can access a supervised clinic-based programme. The purpose of this study was to evaluate the efficacy of telehealth delivered compared with supervised clinic-based delivered exercise and nutrition intervention in overweight/obese patients with prostate cancer. Methods and analysis A single-blinded, two-arm parallel group, non-inferiority randomised trial will be undertaken with 104 overweight/obese men with prostate cancer (body fat percentage ≥ 25%) randomly allocated in a ratio of 1:1 to a telehealth-delivered, virtually supervised exercise and nutrition programme or a clinic-based, face-to-face supervised exercise and nutrition programme. Exercise will consist of supervised resistance and aerobic exercise performed three times a week plus additional self-directed aerobic exercise performed 4 days/week for the first 6 months. Thereafter, for months 7-12, the programmes will be self-managed. The primary endpoint will be fat mass. Secondary endpoints include lean mass and abdominal aortic calcification, anthropometric measures and blood pressure assessment, objective measures of physical function and physical activity levels, patient-reported outcomes and blood markers. Measurements will be undertaken at baseline, 6 months (post intervention), and at 12 months of follow-up. Data will be analysed using intention-to-treat and per protocol approaches. Ethics and dissemination Ethics approval has been obtained from the Edith Cowan University Human Research Ethics Committee (ID: 2021-02157-GALVAO). Outcomes from the study will be published in academic journals and presented in scientific and consumer meetings. Trial registration number: ACTRN12621001312831

time frame for improving emergency care.

<p>time frame for improving emergency care.</p

Patient characteristics in a random sample of 500 patients before and after the intervention took place.

<p>Patient characteristics in a random sample of 500 patients before and after the intervention took place.</p

Body composition, fatigue and exercise in patients with prostate cancer undergoing androgen deprivation therapy

To investigate the association between lean mass (LM) and fat mass (FM) with fatigue and vitality before and following exercise in patients with prostate cancer already undergoing androgen deprivation therapy (ADT).Cross-sectional associations between lean and fat mass with fatigue and/or vitality measures were examined in 229 patients (43-90 years). Prospective analysis was undertaken in 129 patients who underwent 3-6 months exercise (predominantly resistance + aerobic). Whole body and appendicular LM and total and trunk FM were assessed by dual X-ray absorptiometry. Fatigue was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 36 (EORTC QLQ-30) and vitality using the Short Form-36.Based on the EORTC QLQ-30, 19% of patients had clinically relevant fatigue. There was no association between LM and fatigue, however, total (p=0.013), trunk (p=0.015) and percent (p=0.008) FM were higher in fatigued than non-fatigued patients, with total and trunk FM 5.0 kg and 2.6 kg higher, respectively. For quartiles of vitality, a similar pattern emerged for FM with those in the lowest quartile of vitality having the highest FM values (p=0.014-0.034). In contrast, following exercise, change in fatigue and vitality were associated with change in total LM (r=-0.182, p=0.042 and r=0.309, p=0.001, respectively) but not FM. Patients fatigued at baseline but not fatigued following exercise gained a median of 2.1 kg (IQR 0.7-3.2) LM.In prostate cancer patients treated with ADT, body composition is associated with fatigue, with higher total and trunk FM in those with clinically relevant fatigue. However, following exercise those no longer fatigued had an accompanying substantial increase in LM. Modifying a prostate cancer patient's body composition, both lean and fat mass, may favourably alter cancer-related fatigue levels and should be a target of exercise medicine in this population. This article is protected by copyright. All rights reserved

Breakdown of costs of the intervention.

<p>Breakdown of costs of the intervention.</p