The Prevention of Breast and Endometrial cancer using Total Diet Replacement (PROBE-TDR) Trial; Protocol for a Randomised Controlled Trial

Helen Clarke, Michelle Harvie, Cheryl Lombardelli, S. Krizak, Katharine Sellers, Hannah Harrison, Y, Y, Lim, C. Parkin, S. Patel, B. Issa, A. Maxwell, J. Wisley, J. Belcher, Robert Clarke, Tony Howell, Emma Crosbie, Sacha Howell

Research output: Contribution to journalArticlepeer-review


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 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 total diet replacement-induced weight loss, as well as long-term adherence to a 12-month TDR weight loss intervention.
Methods and analysis
PROBE-TDR; the 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 total diet replacement (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 (~2000kcal/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 to 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.
Original languageEnglish
Article numbere057161
JournalBMJ Open
Issue number7
Early online date19 Jul 2022
Publication statusPublished - 19 Jul 2022

Research Beacons, Institutes and Platforms

  • Manchester Cancer Research Centre


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