NCT06343987

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Aarhus University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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 of a 12-week physical activity program in this patient group in terms of adherence, recruitment rate, retention and acceptability. Potential effects on metabolic health, body composition, physical performance, obesity-related biomarkers and patient-related outcomes are explored. The hypothesis is that improving metabolic health and health-related quality of life through physical activity can optimize cancer care. Participants will randomized 2:1 to either a physical activity program or care as usual.

Detailed 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 can live for several years, 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 and quality of life 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 potential effects 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, blood pressure measurements, bioelectrical impedance analysis, physical performance tests, questionnaires on quality of life, self-efficacy of cancer coping, sleep quality and a self-developed evaluation questionnaire, and one individual semi-structured interview. This feasibility study will guide the decision of a future, full-scale study.

Conditions

• Metastatic Breast Cancer
• Estrogen-receptor-positive Breast Cancer
• Adiposity

Interventions

Type	Name	Description
BEHAVIORAL	Physical Activity	12-week physical activity program with training 3 times a week. The training consists of high-intensity training such as weight-lifting and cardiovascular training, and low-intensity training such as relaxation and stretching.

Timeline

• Start date: 2024-02-19
• Primary completion: 2025-04-24
• Completion: 2025-04-24
• First posted: 2024-04-03
• Last updated: 2025-04-27

Locations

1 site across 1 country: Denmark