SEARCHRCToncology, cardiology

RCT·oncology, cardiology, nutrition, clinical nutrition, endocrinology·PMC10404477

Rationale and design of IMPACT-women: a randomised controlled trial of the effect of time-restricted eating, healthy eating and reduced sedentary behaviour on metabolic health during chemotherapy for early-stage breast cancer

The British Journal of Nutrition · 11 authors, 8 centres

AI SUMMARY

FIDELITY 100%

POPULATION130 women scheduled for chemotherapy for early-stage (I–III) breast cancer

INTERVENTIONMultimodal behavioural intervention consisting of time-restricted eating (8h eating window), healthy eating education and counselling, and goal-setting for reduced sedentary time, delivered via telephone by a registered dietitian

COMPARISONUsual cancer and supportive care including a single group-based nutrition class and healthy eating and physical activity guidelines

This summary was generated by AI from a single paper. It has not been reviewed by a clinician and is not clinical advice. Verify against the source before acting on it.

AGENT 01 · STRUCTURED SUMMARY

TRACE TO SOURCE

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TL;DR

This paper describes the rationale and design of the IMPACT-women randomised controlled trial, which will test whether a combined intervention of time-restricted eating, healthy eating, and reduced sedentary time can prevent visceral fat accumulation and cardiometabolic dysfunction during chemotherapy for early-stage breast cancer.

Full summary

848 CHARS

The IMPACT-women study is a protocol for a randomised controlled trial designed to address the metabolic side effects of chemotherapy in early-stage breast cancer. The study will enroll 130 women and randomise them to a multimodal intervention (time-restricted eating, healthy eating, and reduced sedentary behaviour) versus usual care. The intervention involves telephone-based counselling from a registered dietitian. The primary endpoint is the volume of visceral adipose tissue measured by MRI after the completion of chemotherapy, with a 2-year follow-up. Secondary and exploratory outcomes include other body fat depots, cardiometabolic risk factors, and inflammatory markers. The authors cite observational data showing that chemotherapy is linked to new metabolic syndrome in 73% of women and rapid, persistent accumulation of visceral fat.

PICO

PPOPULATION

130 women scheduled for chemotherapy for early-stage (I–III) breast cancer

IINTERVENTION

Multimodal behavioural intervention consisting of time-restricted eating (8h eating window), healthy eating education and counselling, and goal-setting for reduced sedentary time, delivered via telephone by a registered dietitian

OOUTCOME

Primary outcome: visceral adipose tissue volume at the end of chemotherapy. Secondary outcomes include other fat depot volumes, metabolic syndrome z-score, and cardiovascular disease risk scores.

STUDY TYPE

RCT

SPECIALTY

oncology

SUMMARISED BY

AI pipeline

FIDELITY CHECK

100% · A

ORIGINAL PAPER

PMC10404477

Rationale and design of IMPACT-women: a randomised controlled trial of the effect of time-restricted eating, healthy eating and reduced sedentary behaviour on metabolic health during chemotherapy for early-stage breast cancer

The British Journal of Nutrition

READ THE FULL PAPER

ABSTRACT

Metabolic dysfunction and excess accumulation of adipose tissue are detrimental side effects from breast cancer treatment. Diet and physical activity are important treatments for metabolic abnormalities, yet patient compliance can be challenging during chemotherapy treatment. Time-restricted eating (TRE) is a feasible dietary pattern where eating is restricted to 8 h/d with water-only fasting for the remaining 16 h. The purpose of this study is to evaluate the effect of a multimodal intervention consisting of TRE, healthy eating, and reduced sedentary time during chemotherapy treatment for early-stage (I–III) breast cancer on accumulation of visceral fat (primary outcome), other fat deposition locations, metabolic syndrome and cardiovascular disease risk (secondary outcomes) compared with usual care. The study will be a two-site, two-arm, parallel-group superiority randomised control trial enrolling 130 women scheduled for chemotherapy for early-stage breast cancer. The intervention will be delivered by telephone, including 30–60-minute calls with a registered dietitian who will provide instructions on TRE, education and counselling on healthy eating, and goal setting for reducing sedentary time. The comparison group will receive usual cancer and supportive care including a single group-based nutrition class and healthy eating and physical activity guidelines. MRI, blood draws and assessment of blood pressure will be performed at baseline, after chemotherapy (primary end point), and 2-year follow-up. If our intervention is successful in attenuating the effect of chemotherapy on visceral fat accumulation and cardiometabolic dysfunction, it has the potential to reduce risk of cardiometabolic disease and related mortality among breast cancer survivors.

CITATION EXPORT

Rebecca A. G. Christensen, Mark J. Haykowsky, Michelle Nadler et al.. Rationale and design of IMPACT-women: a randomised controlled trial of the effect of time-restricted eating, healthy eating and reduced sedentary behaviour on metabolic health during chemotherapy for early-stage breast cancer. The British Journal of Nutrition. (2023). https://doi.org/10.1017/S0007114522003816

AUTHORS

11 · 8 CENTRES

Rebecca A. G. Christensen, Mark J. Haykowsky, Michelle Nadler, Carla M. Prado, Stephanie D. Small, Julia N. Rickard, Edith Pituskin, D. Ian Paterson, John R. Mackey, Richard B. Thompson, Amy Ashley Kirkham

1Faculty of Kinesiology & Physical Education, University of Toronto, Toronto, ON, Canada
2Faculty of Nursing, University of Alberta, Edmonton, AB, Canada
3Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre, Toronto, ON, Canada
4Department of Agriculture, Food and Nutrition Science, University of Alberta, Edmonton, AB, Canada
5Division of Cardiology, Department of Medicine, University of Alberta, Edmonton, AB, Canada
6Department of Oncology, University of Alberta, Edmonton, AB, Canada
7Department of Biomedical Engineering, University of Alberta, Edmonton, AB, Canada
8KITE, Toronto Rehabilitation Institute, Toronto, ON, Canada