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Completed

NCT Number: NCT06343987

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Oncology, Aarhus University Hospital

Aarhus N, Central Jutland, 8200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Recruitment rate

    Time frame: 1 year

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

  2. Adherence to the training program

    Time frame: 1 year

    Adherence to the training program assessed by the mean attendance rate

  3. Retention

    Time frame: 1,5 years

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

  4. Adherence to other study procedures

    Time frame: 1,5 years

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

  5. Acceptability

    Time frame: 1 year

    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?"

Other outcomes

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

    Time frame: Until the end of study

    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

  2. Metabolic score

    Time frame: Until the end of study

    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

  3. Self-efficacy of cancer coping as assessed by CBI-12

    Time frame: Until end of study

    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.

  4. Sleep quality as assessed by PSQI

    Time frame: Until end of study

    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.

  5. Insomnia as assessed by ISI

    Time frame: Until end of study

    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).

  6. Change in C-reactive protein

    Time frame: 1 year

    Change in circulation levels of C-reactive protein measured in mg/L

  7. Change in leukocytes

    Time frame: 1 year

    Change in circulation levels of total leukocytes measured in 10^9/L

  8. Change in HbA1c

    Time frame: 1 year

    Change in HbA1c measured in mmol/mol

  9. Change in LDL cholesterol

    Time frame: 1 year

    Change in LDL cholesterol measured in mmol/L

  10. Change in HDL cholesterol

    Time frame: 1 year

    Change in HDL cholesterol measured in mmol/L

  11. Change in BMI

    Time frame: 1 year

    Change in BMI kg/m^2

  12. Fat mass

    Time frame: 1 year

    Change in fat mass in kilogram

  13. Muscle mass

    Time frame: 1 year

    Change in muscle mass in kilogram

  14. Visceral fat

    Time frame: 1 year

    Change in visceral fat in kilogram

  15. VO2 max

    Time frame: 1 year

    Change in VO2 max measured by Watt-Max test

  16. Handgrip strength

    Time frame: 1 year

    Change in handgrip strength in kilogram measured by dynamometer after 12 weeks

  17. Sit-rising

    Time frame: 1 year

    Change in number of performed sit-rising in 30 seconds measured through a sitting-rising test

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Collaborators

  • Danish Cancer Society

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 3, 2024
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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