The FEMA Study: Feasibility of Exercise in Patients With Metastatic Breast Cancer and Adiposity

Metastatic Breast Cancer Clinical Trial

Official title: Feasibility of a Physical Activity Program in Patients With Metastatic Breast Cancer and Overweight: a Randomized Controlled Trial

Status Recruiting

Clinical Trial Summary

The goal of this clinical trial is to test a physical activity program in patients with metastatic breast cancer and overweight receiving endocrine-based treatment.

The aim of the study is to assess the feasibility and metabolic efficacy of a 12-week physical activity program in this patient group. The hypothesis is that improving metabolic health through physical activity can optimize cancer care.

Participants will randomized 2:1 to either a physical activity program or care as usual.

Clinical Trial Description

Women with overweight and obesity not only have a greater risk of developing breast cancer; they also have a worse prognosis. At diagnosis, women with overweight are more likely to have more advanced breast cancer and face an elevated risk of developing distant metastases compared to breast cancer patients with normal weight. Despite advanced disease, many patients with metastatic breast cancer live long and productive lives, but experience weight-gain, physical de-conditioning, and decreasing quality of life. On top of this, patients with endocrine-responsive metastatic breast cancer often receive treatment with aromatase inhibitors which can induce metabolic changes, increasing the risk of weight-gain and type 2 diabetes. The hypothesis is that improving metabolic health through physical activity in patients with metastatic breast cancer and overweight receiving endocrine-based treatment can optimize cancer care.

Therefore, in this randomized controlled trial, the investigators will launch a 12-week physical intervention program including 21 participants to investigate the feasibility and metabolic efficacy hereof. The program will take place at Steno Diabetes Centre Aarhus, and patients are included from the Department of Oncology, Aarhus University Hospital. The physical activity program consists of training 3 times a week with a supervising physiotherapist. Throughout the study, data will be collected through blood samples, clinical measures such as blood pressure, weight and bioimpedance, physical performance, questionnaires on quality of life, self-efficacy of cancer coping, sleep quality and feedback on the training program, and one final individual interview.

This intervention study holds significance on multiple fronts. It not only aims to enhance cancer care for our specific patient group but also to: 1) Help us understand the clinical and translational metabolic factors associated with excess weight and their impact on mental health and quality of life; 2) improve cancer care for all metastatic breast cancer patients, regardless of their weight status; and 3) potentially improve cancer care for all breast cancer patients receiving endocrine-based treatments. ;

Related Conditions & MeSH terms

• Adiposity
• Breast Neoplasms
• Metastatic Breast Cancer
• Obesity

• NCT number: NCT06343987
• Study type: Interventional
• Source: Aarhus University Hospital
• Contact: Signe SB Borgquist, MD, PhD
• Phone: +45 22 62 45 25
• Email: signe.borgquist@auh.rm.dk
• Status: Recruiting
• Phase: N/A
• Start date: February 19, 2024
• Completion date: March 2025