Department of Oncology, Aarhus University Hospital
Aarhus N, Central Jutland, 8200, Denmark
NCT Number: NCT06343987
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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Notify Me18 year and older
Female
Interventional
Not applicable
Aarhus N, Central Jutland, 8200, Denmark
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 1 year
Recruitment rate calculated by the amount of included partcipants of those eligible
Time frame: 1 year
Adherence to the training program assessed by the mean attendance rate
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
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
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?"
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
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
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.
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.
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).
Time frame: 1 year
Change in circulation levels of C-reactive protein measured in mg/L
Time frame: 1 year
Change in circulation levels of total leukocytes measured in 10^9/L
Time frame: 1 year
Change in HbA1c measured in mmol/mol
Time frame: 1 year
Change in LDL cholesterol measured in mmol/L
Time frame: 1 year
Change in HDL cholesterol measured in mmol/L
Time frame: 1 year
Change in BMI kg/m^2
Time frame: 1 year
Change in fat mass in kilogram
Time frame: 1 year
Change in muscle mass in kilogram
Time frame: 1 year
Change in visceral fat in kilogram
Time frame: 1 year
Change in VO2 max measured by Watt-Max test
Time frame: 1 year
Change in handgrip strength in kilogram measured by dynamometer after 12 weeks
Time frame: 1 year
Change in number of performed sit-rising in 30 seconds measured through a sitting-rising test
Aarhus University Hospital
Other
Feasibility of a Physical Activity Program in Patients With Metastatic Breast Cancer and Overweight: a Randomized Controlled Trial
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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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