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Prevention Of Breast and Endometrial cancer using Total Diet Replacement (PROBE-TDR) trial: protocol for a randomised controlled trial
Clarke, Helen Harvie, M. Lombardelli, C. Krizak, S. Sellers, K. Harrison, Hannah Lim, Y. Y. Parkin, C. Patel, S. Issa, B. G.
Clarke, Helen
Harvie, M.
Lombardelli, C.
Krizak, S.
Sellers, K.
Harrison, Hannah
Lim, Y. Y.
Parkin, C.
Patel, S.
Issa, B. G.
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Abstract
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.
Description
Date
2022
Publisher
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Keywords
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Article
Citation
Clarke H, Harvie M, Lombardelli C, Krizak S, Sellers K, Harrison H, et al. Prevention Of Breast and Endometrial cancer using Total Diet Replacement (PROBE-TDR) trial: protocol for a randomised controlled trial. BMJ open. 2022 Jul;12(7). PubMed PMID: WOS:000828326000022.