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

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

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.

Study Overview

• Status: Completed
• Conditions: Metastatic Breast Cancer; Adiposity; Estrogen-receptor-positive Breast Cancer
• Intervention / Treatment: Behavioral: Physical Activity

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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Central Denmark Region
    • Aarhus N, Central Denmark Region, Denmark, 8200
      • Department of Oncology, Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm; 14 participants	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.
No Intervention: Observational Arm; 7 participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived satisfaction assessed by qualitative interviews	Assess the participants' satisfaction and personal experiences in the program through personal interviews, following a self-developed interview guide.	1 year
Health-related quality of life as assessed by EORTC-QLQ-30	Change in health-related quality of life measured with European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30	1 year
Cancer coping as assessed by CBI-12	Change in cancer coping measured with Cancer Behavior Inventory-12 (CBI-12)	1 year
Sleep quality as assessed by PSQI	Change in sleep quality measured with Pittsburgh Sleep Quality Index (PSQI)	1 year
Insomnia as assessed by ISI	Change in insomnia assessed by Insomnia Severity Index (ISI)	1 year
Change in C-reactive protein	Change in circulation levels of C-reactive protein measured in mg/L	1 year
Change in leukocytes	Change in circulation levels of total leukocytes measured in 10^9/L	1 year
Change in HbA1c	Change in HbA1c measured in mmol/mol	1 year
Change in LDL cholesterol	Change in LDL cholesterol measured in mmol/L	1 year
Change in HDL cholesterol	Change in HDL cholesterol measured in mmol/L	1 year
Change in BMI	Change in BMI kg/m^2	1 year
Fat mass	Change in fat mass in kilogram	1 year
Muscle mass	Change in muscle mass in kilogram	1 year
Visceral fat	Change in visceral fat in kilogram	1 year
VO2 max	Change in VO2 max measured by Watt-Max test	1 year
Handgrip strength	Change in handgrip strength in kilogram measured by dynamometer after 12 weeks	1 year
Sit-rising	Change in number of performed sit-rising in 30 seconds measured through a sitting-rising test	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in C-reactive protein	Change in circulation levels of C-reactive protein measured in mg/L	1 year
Change in leukocytes	Change in circulation levels of total leukocytes measured in 10^9/L	1 year
Change in HbA1c	Change in HbA1c measured in mmol/mol	1 year
Change in LDL cholesterol	Change in LDL cholesterol measured in mmol/L	1 year
Change in HDL cholesterol	Change in HDL cholesterol measured in mmol/L	1 year
Change in BMI	Change in BMI kg/m^2	1 year
Fat mass	Change in fat mass in kilogram	1 year
Muscle mass	Change in muscle mass in kilogram	1 year
Visceral fat	Change in visceral fat in kilogram	1 year
VO2 max	Change in VO2 max measured by Watt-Max test	1 year
Handgrip strength	Change in handgrip strength in kilogram measured by dynamometer after 12 weeks	1 year
Sit-rising	Change in number of performed sit-rising in 30 seconds measured through a sitting-rising test	1 year
Health-related quality of life as assessed by EORTC-QLQ-30	Change in health-related quality of life measured with European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30. The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status/QoL scale, and six single items, with 30 items in total. All scales and single-item measures range in score from 0 to 100. A high score on the functional scale represents a high level of functioning, a high score for the global health status represents a high HRQoL, but a high score on a symptom scale represents a high level of symptomatology	Until the end of study
Metabolic score	Change in metabolic score calculated as the sum of Z-transformed levels of mid-blood pressure [(systolic blood pressure + diastolic blood pressure)/2], glucose, and triglycerides. A higher score indicates a worse metabolic health	Until the end of study
Self-efficacy of cancer coping as assessed by CBI-12	Change in self-efficacy in coping with cancer measured with Cancer Behavior Inventory-12 (CBI-12). The questionnaire is scored as a one-dimensional scale, summing the ratings for the items. A higher score indicates higher levels of self-efficacy, with a maximum score of 108.	Until end of study
Sleep quality as assessed by PSQI	Change in sleep quality measured with Pittsburgh Sleep Quality Index (PSQI). The questionnaire consists of 19 items grouped into seven component scores. The directionality and interpretation of scores vary across items. A total score ranging from 0 to 21 can be calculated, with a higher score indicating poorer sleep quality. A score < 5 indicates good sleep quality.	Until end of study
Insomnia as assessed by ISI	Change in insomnia assessed by Insomnia Severity Index (ISI). It contains 7 items and is scored on a one-dimensional scale with a maximum score of 28. The total score is grouped into four categories: no insomnia (0-7), subclinical insomnia (8-14), clinical insomnia (15-21) and severe clinical insomnia (22-28).	Until end of study

Collaborators and Investigators

• Sponsor: Aarhus University Hospital
• Collaborators: Danish Cancer Society
• Investigators: Principal Investigator: Signe SB Borgquist, MD, PhD, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2024
• Primary Completion (Actual): April 24, 2025
• Study Completion (Actual): April 24, 2025

Study Registration Dates

• First Submitted: March 6, 2024
• First Submitted That Met QC Criteria: March 27, 2024
• First Posted (Actual): April 3, 2024

Study Record Updates

• Last Update Posted (Actual): April 27, 2025
• Last Update Submitted That Met QC Criteria: April 24, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Physical Activity; Obesity; Metastatic Breast Cancer; Endocrine Therapy; Adiposity
• Additional Relevant MeSH Terms: Nutrition Disorders; Neoplasms by Site; Neoplasms; Overnutrition; Body Weight; Skin Diseases; Breast Diseases; Overweight; Obesity; Breast Neoplasms
• Other Study ID Numbers: 1-10-72-165-23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No