Prevention Of Breast and Endometrial cancer using Total Diet Replacement (PROBE-TDR) trial: protocol for a randomised controlled trial
Introduction Obesity and overweight are strong potentially modifiable risk factors for postmenopausal breast and endometrial cancer. Bariatric surgery can achieve considerable weight loss and risk reduction of weight-related cancer but is unlikely to be a feasible cancer prevention strategy. Total d...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2022-07-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/7/e057161.full |
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| author | Robert Clarke Emma J Crosbie Basil G Issa John Belcher Helen Clarke Anthony Howell Michelle Harvie Hannah Harrison Cheryl Lombardelli Suzanne Krizak Katharine Sellers Yit Y Lim Caroline Parkin Shruthi Patel Anthony J Maxwell Julie Wisely Sacha J Howell |
| author_facet | Robert Clarke Emma J Crosbie Basil G Issa John Belcher Helen Clarke Anthony Howell Michelle Harvie Hannah Harrison Cheryl Lombardelli Suzanne Krizak Katharine Sellers Yit Y Lim Caroline Parkin Shruthi Patel Anthony J Maxwell Julie Wisely Sacha J Howell |
| author_sort | Robert Clarke |
| collection | DOAJ |
| description | Introduction Obesity and overweight are strong potentially modifiable risk factors for postmenopausal breast and endometrial cancer. Bariatric surgery can achieve considerable weight loss and risk reduction of weight-related cancer but is unlikely to be a feasible cancer prevention strategy. Total diet replacement (TDR) can also lead to significant weight reduction. This study aims to examine the cellular and molecular changes in breast and endometrial tissue in high-risk women following TDR-induced weight loss, as well as longer-term adherence to a 12-month TDR weight loss intervention.Methods and analysis PROBE-TDR (PRevention Of Breast and Endometrial cancer using Total Diet Replacement) is a prospective, non-blinded, randomised controlled trial of 47 women at increased risk of breast and/or endometrial cancer. Randomisation is 2:1 to either an immediate 12-month TDR weight loss programme (n=31) or delayed dietary intervention (control) (n=16). The TDR programme includes an initial 12-week period of TDR (850 kcal/day) followed by a 40-week food-based diet, based on the nutritional principles of a Mediterranean diet, as either continued weight loss (~1500 kcal/day) or weight loss maintenance (~2000 kcal/day). Menstrual phase-matched biopsies of the breast and endometrium will be assessed at baseline and at the end of the 12-week TDR in the immediate diet group, compared with women randomised to the control group following their usual diet. The trial will also assess longer-term adherence and weight loss success across the 12-month programme in both the immediate and control groups.Ethics and dissemination Approval for this study has been obtained from the Health Research Authority and Health and Care Research Wales (approval 20/NW/0095). Results will be published in peer-reviewed journals, presented at conferences and shared with trial participants.Trial registration number International Standard Randomised Controlled Trial Number Registry (ISRCTN15358157). |
| format | Article |
| id | doaj-art-51c616d1d18144f2b5a2595f0689940c |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-07-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-51c616d1d18144f2b5a2595f0689940c2025-01-31T07:55:10ZengBMJ Publishing GroupBMJ Open2044-60552022-07-0112710.1136/bmjopen-2021-057161Prevention Of Breast and Endometrial cancer using Total Diet Replacement (PROBE-TDR) trial: protocol for a randomised controlled trialRobert Clarke0Emma J Crosbie1Basil G Issa2John Belcher3Helen Clarke4Anthony Howell5Michelle Harvie6Hannah Harrison7Cheryl Lombardelli8Suzanne Krizak9Katharine Sellers10Yit Y Lim11Caroline Parkin12Shruthi Patel13Anthony J Maxwell14Julie Wisely15Sacha J Howell16Breast Biology Research Group, Division of Cancer Sciences, Oglesby Cancer Research Building, The University of Manchester, Manchester, UKGynaecological Oncology Research Group, Division of Cancer Sciences, 5th Floor Research, St Mary`s Hospital, The University of Manchester, Manchester, UKManchester University NHS Foundation Trust, Manchester, UKFaculty of Health, Keele University, Keele, UKBreast Biology Research Group, Division of Cancer Sciences, Oglesby Cancer Research Building, The University of Manchester, Manchester, UK8 Prevent Breast Cancer Centre, Manchester, UKManchester University NHS Foundation Trust, Manchester, UKBreast Biology Research Group, Division of Cancer Sciences, Oglesby Cancer Research Building, The University of Manchester, Manchester, UKThe Nightingale and Prevent Breast Cancer Centre, Manchester University NHS Foundation Trust, Manchester, UKManchester University NHS Foundation Trust, Manchester, UKThe Nightingale and Prevent Breast Cancer Centre, Manchester University NHS Foundation Trust, Manchester, UKDepartment of Radiology, Manchester University NHS Foundation Trust, Manchester, UKDepartment of Radiology, Manchester University NHS Foundation Trust, Manchester, UKDepartment of Radiology, Manchester University NHS Foundation Trust, Manchester, UKThe Nightingale and Prevent Breast Cancer Centre, Manchester University NHS Foundation Trust, Manchester, UKGreater Manchester Mental Health NHS Foundation Trust, Manchester, UKThe Nightingale and Prevent Breast Cancer Centre, Manchester University NHS Foundation Trust, Manchester, UKIntroduction Obesity and overweight are strong potentially modifiable risk factors for postmenopausal breast and endometrial cancer. Bariatric surgery can achieve considerable weight loss and risk reduction of weight-related cancer but is unlikely to be a feasible cancer prevention strategy. Total diet replacement (TDR) can also lead to significant weight reduction. This study aims to examine the cellular and molecular changes in breast and endometrial tissue in high-risk women following TDR-induced weight loss, as well as longer-term adherence to a 12-month TDR weight loss intervention.Methods and analysis PROBE-TDR (PRevention Of Breast and Endometrial cancer using Total Diet Replacement) is a prospective, non-blinded, randomised controlled trial of 47 women at increased risk of breast and/or endometrial cancer. Randomisation is 2:1 to either an immediate 12-month TDR weight loss programme (n=31) or delayed dietary intervention (control) (n=16). The TDR programme includes an initial 12-week period of TDR (850 kcal/day) followed by a 40-week food-based diet, based on the nutritional principles of a Mediterranean diet, as either continued weight loss (~1500 kcal/day) or weight loss maintenance (~2000 kcal/day). Menstrual phase-matched biopsies of the breast and endometrium will be assessed at baseline and at the end of the 12-week TDR in the immediate diet group, compared with women randomised to the control group following their usual diet. The trial will also assess longer-term adherence and weight loss success across the 12-month programme in both the immediate and control groups.Ethics and dissemination Approval for this study has been obtained from the Health Research Authority and Health and Care Research Wales (approval 20/NW/0095). Results will be published in peer-reviewed journals, presented at conferences and shared with trial participants.Trial registration number International Standard Randomised Controlled Trial Number Registry (ISRCTN15358157).https://bmjopen.bmj.com/content/12/7/e057161.full |
| spellingShingle | Robert Clarke Emma J Crosbie Basil G Issa John Belcher Helen Clarke Anthony Howell Michelle Harvie Hannah Harrison Cheryl Lombardelli Suzanne Krizak Katharine Sellers Yit Y Lim Caroline Parkin Shruthi Patel Anthony J Maxwell Julie Wisely Sacha J Howell Prevention Of Breast and Endometrial cancer using Total Diet Replacement (PROBE-TDR) trial: protocol for a randomised controlled trial BMJ Open |
| title | Prevention Of Breast and Endometrial cancer using Total Diet Replacement (PROBE-TDR) trial: protocol for a randomised controlled trial |
| title_full | Prevention Of Breast and Endometrial cancer using Total Diet Replacement (PROBE-TDR) trial: protocol for a randomised controlled trial |
| title_fullStr | Prevention Of Breast and Endometrial cancer using Total Diet Replacement (PROBE-TDR) trial: protocol for a randomised controlled trial |
| title_full_unstemmed | Prevention Of Breast and Endometrial cancer using Total Diet Replacement (PROBE-TDR) trial: protocol for a randomised controlled trial |
| title_short | Prevention Of Breast and Endometrial cancer using Total Diet Replacement (PROBE-TDR) trial: protocol for a randomised controlled trial |
| title_sort | prevention of breast and endometrial cancer using total diet replacement probe tdr trial protocol for a randomised controlled trial |
| url | https://bmjopen.bmj.com/content/12/7/e057161.full |
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