Clinical trial · Interventional
Dance-Based Exercise for Cancer-Related Fatigue in Breast Cancer Patients
The Effect of a Dance-Based Exercise Intervention on Cancer-Related Fatigue in Breast Cancer Patients Undergoing Neoadjuvant Treatment: A Randomized Controlled Study.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 15, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260915-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dance-Based Exercise Program | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dance-Based Exercise Intervention
- description
- Participants receive standard neoadjuvant oncological treatment and participate in a supervised 12-week dance-based exercise program.
- interventionNames
- Other: Dance-Based Exercise Program
- type
- NO_INTERVENTION
- label
- Standard Care Control
- description
- Participants receive standard neoadjuvant oncological treatment without participation in the structured dance-based exercise program.
Primary outcomes (1)
- measure
- Change in Cancer-Related Fatigue Assessed by the FACIT-Fatigue Scale
- timeFrame
- Baseline to the end of the 12-week intervention
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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.
References
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