NCT04298086

A Study of the Body's Response to Exercise and a Plant-Based Diet in Overweight Postmenopausal Women With Breast Cancer

Pharmacodynamic Response to Exercise Treatment and Plant-Based Diet in Overweight/Obese Postmenopausal Women With Primary Hormone Receptor Positive Breast Cancer: A Phase 2 Randomized Control Trial

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out what effects, if any, exercise and a plant-based diet have on aromatase levels in postmenopausal women who are overweight and being treated with an aromatase inhibitor for their HR+ breast cancer. The study will also look at other ways diet and exercise may affect your body (for example, changing the way your breast tissue expresses or makes genes) and your quality of life.

Conditions

• Breast Cancer
• Primary Hormone Receptor Positive Breast Cancer

Interventions

Type	Name	Description
OTHER	Exercise Treatment	Exercise treatment will consist of individualized walking delivered up to 7 times weekly to achieve the patient-specific goal energy expenditure. Training sessions will be performed on a treadmill at under remote surveillance using a telemedicine approach (i.e.,TeleEx) established in the Exercise-Oncology (ExOnc) Service.
OTHER	Plant-Based Diet	Pre-prepared meals, including 6 dinners and 6 lunches per week, will be shipped to the partipant's home during the intervention.
OTHER	Physical activity	Treadmills and low-calorie recipes will be provided to patients in the counseling arm.
OTHER	Nutrition counseling	Nutrition program including regular counseling by exercise physiologists and registered dieticians (RDs).
OTHER	Replication Exercise Test	Exercise capacity will be reassessed by a replication exercise test at week 6 in the intervention group only.

Timeline

• Start date: 2020-03-04
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2020-03-06
• Last updated: 2025-07-11

Locations

7 sites across 1 country: United States