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...
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BMJ Publishing Group
2022-06-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/6/e058899.full |
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| author | Robert U Newton Daniel A Galvão Dennis R Taaffe Suzanne K Chambers David Joseph Amanda Devine Colin I Tang Nigel Spry Emily Jeffery Dickon Hayne Pedro Lopez P Lyons-Wall Christine Kudiarasu |
| author_facet | Robert U Newton Daniel A Galvão Dennis R Taaffe Suzanne K Chambers David Joseph Amanda Devine Colin I Tang Nigel Spry Emily Jeffery Dickon Hayne Pedro Lopez P Lyons-Wall Christine Kudiarasu |
| author_sort | Robert U Newton |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-e154145009f94b81a2c67347346ca378 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-06-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-e154145009f94b81a2c67347346ca3782025-01-24T17:35:13ZengBMJ Publishing GroupBMJ Open2044-60552022-06-0112610.1136/bmjopen-2021-058899Weight 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)Robert U Newton0Daniel A Galvão1Dennis R Taaffe2Suzanne K Chambers3David Joseph4Amanda Devine5Colin I Tang6Nigel Spry7Emily Jeffery8Dickon Hayne9Pedro Lopez10P Lyons-Wall11Christine Kudiarasu122 School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, AustraliaExercise Medicine Research Institute, Edith Cowan University, Joondalup, Western Australia, AustraliaSchool of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, AustraliaFaculty of Health Sciences, Australian Catholic University, Brisbane, Queensland, Australia1 Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, Connecticut, USASchool of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, AustraliaDepartment of Radiation Oncology, Sir Charles Gairdner Hospital, Perth, Western Australia, AustraliaExercise Medicine Research Institute, Edith Cowan University, Joondalup, Western Australia, AustraliaSchool of Public Health, Curtin University, Perth, Western Australia, Australia2 UWA Medical School, University of Western Australia, Crawley, Western Australia, Australia4 Programa de Pós-Graduação em Ciências da Saúde, Universidade de Caxias do Sul, Caxias do Sul, Rio Grande do Sul, BrazilExercise Medicine Research Institute, Edith Cowan University, Joondalup, Western Australia, AustraliaExercise Medicine Research Institute, Edith Cowan University, Joondalup, Western Australia, AustraliaIntroduction 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.https://bmjopen.bmj.com/content/12/6/e058899.full |
| spellingShingle | Robert U Newton Daniel A Galvão Dennis R Taaffe Suzanne K Chambers David Joseph Amanda Devine Colin I Tang Nigel Spry Emily Jeffery Dickon Hayne Pedro Lopez P Lyons-Wall Christine Kudiarasu 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) BMJ Open |
| title | 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) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/12/6/e058899.full |
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