Breast Neoplasms
Conditions
Keywords
Physical Exercise, Breast Cancer, Quality of Life, Gut Microbiome, Dance
Brief summary
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.
Detailed description
Cancer-related fatigue is one of the most prevalent and burdensome symptoms experienced by patients with breast cancer during systemic anticancer treatment. Unlike ordinary tiredness, cancer-related fatigue may persist despite rest and can negatively affect physical functioning, psychological well-being, daily activities, and quality of life. Exercise has been recognized as an important supportive strategy for the management of cancer-related fatigue; however, adherence to conventional exercise programs during intensive cancer treatment may be challenging. Dance-based exercise represents a multimodal form of physical activity combining aerobic exercise, coordination, balance, rhythmic movement, and social and cognitive engagement. Its enjoyable and adaptable nature may provide an alternative approach to maintaining physical activity during cancer treatment. Nevertheless, evidence regarding the effects of structured dance-based exercise during neoadjuvant treatment for breast cancer remains limited. This randomized controlled study will investigate the effects of a structured dance-based exercise intervention in women with breast cancer undergoing neoadjuvant treatment. The study is designed to determine whether incorporating supervised dance-based exercise into the period of neoadjuvant treatment can reduce cancer-related fatigue and support physical and psychosocial functioning compared with standard oncological care alone. The intervention is structured as a progressive, supervised dance-based exercise program delivered during neoadjuvant treatment. The program combines dance-based aerobic activity with movements targeting coordination, mobility, balance, and muscular function. Exercise intensity and complexity will be individually adapted according to participants' physical condition, exercise tolerance, and treatment-related symptoms. This approach is intended to maintain an appropriate exercise stimulus while allowing flexibility in response to changes in health status during oncological treatment. In addition to evaluating the clinical and functional effects of the intervention, the study includes an exploratory mechanistic component. Cancer treatment and physical activity may influence systemic metabolism, inflammatory processes, and the intestinal microbial ecosystem. The study will therefore investigate changes in the gut microbiome and selected circulating biological markers and explore their relationships with changes in fatigue, physical fitness, body composition, physical activity, and other clinical and functional characteristics. The gut microbiome component will characterize microbial composition and diversity using stool samples collected during the study. Blood-based analyses will complement the microbiome assessment by examining selected biological pathways potentially involved in the response to exercise and cancer treatment. Integrating these biological data with functional and patient-reported data may provide insight into mechanisms through which exercise influences health and recovery during neoadjuvant breast cancer treatment. The longitudinal design will also allow the investigators to examine whether changes observed during the intervention period are maintained during recovery following surgery. By combining a randomized exercise intervention with clinical, functional, behavioral, and biological assessments, the study aims to provide a comprehensive evaluation of dance-based exercise as a supportive strategy during neoadjuvant treatment for breast cancer.
Interventions
Participants 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.
Sponsors
Comenius University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Parallel assignment with two groups: a dance-based exercise intervention plus standard oncological care and a control group receiving standard oncological care alone. Participants are randomized in a 1:1 ratio.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Signed and dated written informed consent. Female patients with histologically confirmed, newly diagnosed, non-metastatic invasive breast cancer. Age 18-60 years. Body mass index (BMI) \<35 kg/m². Indication for and planned initiation of neoadjuvant treatment at the National Cancer Institute in Bratislava, Slovakia, or St. Elizabeth Cancer Institute in Bratislava, Slovakia. Planned definitive breast surgery following completion of neoadjuvant treatment. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. Ability to understand and complete the study questionnaires and comply with study procedures. Ability and willingness to participate in the supervised dance intervention, as determined by the investigator. Medical clearance for participation in moderate-intensity physical activity.
Exclusion criteria
Metastatic breast cancer at the time of study enrollment. Recurrent breast cancer or previous treatment for the current breast cancer, except for diagnostic biopsy and other diagnostic procedures. Previous invasive malignancy within the preceding 5 years, except for adequately treated non-melanoma skin cancer, carcinoma in situ, or another malignancy considered by the investigator unlikely to interfere with study outcomes. ECOG performance status ≥2. Any uncontrolled cardiovascular, respiratory, neurological, musculoskeletal, or other medical condition that, in the investigator's judgment, would make participation in the dance intervention unsafe. Clinically significant laboratory abnormalities that, in the investigator's judgment, would make participation in the physical intervention unsafe. Pregnancy or breastfeeding. Inability or unwillingness to comply with study procedures, the intervention schedule, sample collection, or follow-up assessments. Any psychological, cognitive, social, or language-related condition that would prevent provision of valid informed consent or reliable completion of study assessments.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cancer-Related Fatigue Assessed by the FACIT-Fatigue Scale | Baseline to the end of the 12-week intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life | Baseline to the end of the 12-week intervention | 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. |
| Change in Cardiorespiratory Fitness | Baseline to the end of the 12-week intervention | Cardiorespiratory fitness (VO2max) will be assessed using a bicycle exercise test. Changes in exercise capacity from baseline will be evaluated. |
| Change in Lower and Upper-Body Muscular Strength | Baseline to the end of the 12-week intervention | Muscular Strength will be assessed using the functional/strength test specified in the study protocol. Changes from baseline will be evaluated. |
| Change in Gut Microbiome Diversity and Composition | Baseline to the end of the 12-week intervention | Gut microbial composition will be characterized from stool samples to assess changes in the relative abundance of bacterial taxa associated with the intervention. |
| Change in Inflammatory Biomarkers | Baseline to the end of the 12-week intervention | Blood samples will be analyzed for selected circulating biomarkers related to systemic inflammation. Changes in biomarker concentrations from baseline will be evaluated. |
| Change in Markers of Intestinal Permeability | Baseline to the end of the 12-week intervention | Blood samples will be analyzed for selected biomarkers related to intestinal barrier function and permeability. Changes from baseline will be evaluated. |
| Long-Term Cancer-Related Fatigue | Approximately 90, 180, and 365 days after surgery | ancer-related fatigue will be reassessed after surgery using the FACIT-Fatigue scale to evaluate the persistence of intervention-related effects during follow-up. Higher scores indicate less fatigue. |
| Long-Term Quality of Life | Approximately 90, 180, and 365 days after surgery | Quality of life will be reassessed during postoperative follow-up using the study-specified validated questionnaire to evaluate longer-term differences between groups. |
Countries
Slovakia
Contacts
CONTACTZuzana Orsághová, PhD, MD
CONTACTBela Mriňáková, PhD., MD
PRINCIPAL_INVESTIGATORMichal Mego, PhD, MD
2nd Department of Oncology, Faculty of Medicine, Comenius University, Bratislava and National Cancer Institute, Bratislava, Slovakia
PRINCIPAL_INVESTIGATORViktor Bielik, PhD.
Department of Biological and Medical Sciences, Faculty of Physical Education and Sport, Comenius University in Bratislava, Bratislava, Slovakia
Outcome results
None listed