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

NCT ID: NCT06343987

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-19
• Study Completion Date: 2025-04-24

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention Arm

14 participants

Group Type: EXPERIMENTAL

Physical Activity

Intervention Type: BEHAVIORAL

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.

Observational Arm

7 participants

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Diagnosed metastatic breast cancer
• BMI ≥ 25
• Receive first-line endocrine-based therapy
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1

Exclusion Criteria

• Psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; these conditions will be discussed with the patient before registration in the trial.
• Physical health condition that either is unsafe for participation or prevents the patient from participating adequately in the physical activity program.
• Pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Danish Cancer Society

OTHER

Sponsor Role: collaborator

Aarhus University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Signe Borgquist

Chair Professor, Senior Consultant, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Signe SB Borgquist, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

Department of Oncology, Aarhus University Hospital

Aarhus N, Central Jutland, Denmark

Countries

Denmark

References

Wissing M, Skovlund P, Drysdale S, Amidi A, Zachariae R, Laurberg T, Borgquist S. Feasibility of an exercise program in endocrine-treated metastatic breast cancer patients with overweight: protocol for the FEMA study. Pilot Feasibility Stud. 2025 Apr 2;11(1):36. doi: 10.1186/s40814-025-01621-9.

Reference Type: DERIVED

PMID: 40176194 (View on PubMed)

Other Identifiers

1-10-72-165-23

Identifier Type: -

Identifier Source: org_study_id