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

NCT06343987 | Completed DMC

• 1 other identifier: 1-10-72-165-23
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Metastatic Breast Cancer; Physical Activity; Adiposity; Endocrine Therapy; Obesity

Outcome Measures

Primary Outcomes (5)

• Recruitment rate

  Recruitment rate calculated by the amount of included partcipants of those eligible

  1 year

• Adherence to the training program

  Adherence to the training program assessed by the mean attendance rate

  1 year

• Retention

  Retention rate to the study assessed by the proportion of participants in each study arm that completes the study period

  1,5 years

• Adherence to other study procedures

  Adherence to other study procedures assessed by the proportion of completed questionnaires and blood samples at the specified time-points

  1,5 years

• Acceptability

  Acceptability of the study intervention assessed by the proportion of participants in the intervention arm that anwers "yes" to the question: "Would you recommend others to participate in the physical activity program?"

  1 year

Other Outcomes (17)

• Health-related quality of life as assessed by EORTC-QLQ-30

  Until the end of study

• Metabolic score

  Until the end of study

• Self-efficacy of cancer coping as assessed by CBI-12

  Until end of study

Study Arms (2)

Intervention Arm

EXPERIMENTAL

14 participants

Behavioral: Physical Activity

Observational Arm

NO INTERVENTION

7 participants

Interventions

Physical Activity 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.

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aarhus University Hospital: lead
• Danish Cancer Society: collaborator

Study Sites (1)

Department of Oncology, Aarhus University Hospital

Aarhus N, Central Jutland, 8200, Denmark

Location

Related Publications (1)

• 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.

  PMID: 40176194 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Obesity; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Signe SB Borgquist, MD, PhD

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair Professor, Senior Consultant, PhD

Model Details: Continuous inclusion. Randomized 2:1 - intervention group and observational group, respectively.

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: April 3, 2024
• Study Start: February 19, 2024
• Primary Completion: April 24, 2025
• Study Completion: April 24, 2025
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)