Dance-Based Exercise for Cancer-Related Fatigue in Breast Cancer Patients
ConditionBreast Neoplasms
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-60
SponsorComenius University
About this trial
The goal of this clinical trial is to learn whether a 12-week dance-based exercise program can reduce cancer-related fatigue in women with newly diagnosed breast cancer who are undergoing treatment before surgery. The main questions it aims to answer are:
Does participating in the dance-based exercise program reduce cancer-related fatigue? Does the program improve quality of life and physical functioning?
Researchers will compare women who participate in the dance-based exercise program in addition to their standard cancer care with women who receive standard cancer care alone.
Participants in the dance group will take part in supervised 60-minute dance sessions three times per week for 12 weeks. All participants will complete questionnaires and undergo assessments of physical fitness and body composition. Blood and stool samples will also be collected to study changes in the gut microbiome and selected biological markers. Participants will be followed for up to one year after surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Dance-Based Exercise Program
Other interventionParticipants will complete a 12-week supervised dance-based exercise program consisting of three 60-minute sessions per week. Each session will include a warm-up, a main dance-based exercise component, and a cool-down. The program will combine aerobic dance activities with exercises targeting coordination, balance, mobility, and muscular function. Exercise intensity and complexity will be individually adapted according to participants' physical condition, exercise tolerance, and treatment-related symptoms.
Treatment groups
104 Participants
are divided into 2 treatment groupsGroup A: Dance-Based Exercise InterventionExperimental treatment 1 intervention
Group B: Standard Care ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in Cancer-Related Fatigue Assessed by the FACIT-Fatigue Scale
Cancer-related fatigue will be assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) scale. The total score ranges from 0 to 52, with higher scores indicating less fatigue (better functioning). The primary analysis will evaluate the change in FACIT-Fatigue score from baseline to the end of the 12-week intervention.
Time frame
Baseline to the end of the 12-week interventionSecondary outcomes
1
Change in Quality of Life
Quality of life will be assessed using the study-specified validated quality-of-life questionnaire. The relevant total and/or domain scores will be calculated according to the questionnaire scoring instructions.
Time frame
Baseline to the end of the 12-week intervention2
Change in Cardiorespiratory Fitness
Cardiorespiratory fitness (VO2max) will be assessed using a bicycle exercise test. Changes in exercise capacity from baseline will be evaluated.
Time frame
Baseline to the end of the 12-week intervention3
Change in Lower and Upper-Body Muscular Strength
Muscular Strength will be assessed using the functional/strength test specified in the study protocol. Changes from baseline will be evaluated.
Time frame
Baseline to the end of the 12-week intervention4
Change in Gut Microbiome Diversity and Composition
Gut microbial composition will be characterized from stool samples to assess changes in the relative abundance of bacterial taxa associated with the intervention.
Time frame
Baseline to the end of the 12-week interventionSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: