Dance-Based Exercise for Cancer-Related Fatigue in Breast Cancer Patients

NCT07817355 | Not Yet Recruiting

• 1 other identifier: 1/0437/27
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms

Keywords

Physical Exercise; Breast Cancer; Quality of Life; Gut Microbiome; Dance

Outcome Measures

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.

  Baseline to the end of the 12-week intervention

Secondary Outcomes (8)

• Change in Quality of Life

  Baseline to the end of the 12-week intervention

• Change in Cardiorespiratory Fitness

  Baseline to the end of the 12-week intervention

• Change in Lower and Upper-Body Muscular Strength

  Baseline to the end of the 12-week intervention

• Change in Gut Microbiome Diversity and Composition

  Baseline to the end of the 12-week intervention

• Change in Inflammatory Biomarkers

  Baseline to the end of the 12-week intervention

Study Arms (2)

Dance-Based Exercise Intervention

EXPERIMENTAL

Participants receive standard neoadjuvant oncological treatment and participate in a supervised 12-week dance-based exercise program.

Other: Dance-Based Exercise Program

Standard Care Control

NO INTERVENTION

Participants receive standard neoadjuvant oncological treatment without participation in the structured dance-based exercise program.

Interventions

Dance-Based Exercise Program OTHER

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.

Dance-Based Exercise Intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Comenius University: lead

Study Sites (1)

2nd Department of Oncology, Faculty of Medicine, Comenius University and National Cancer Institute

Bratislava, 83310, Slovakia

Location

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Study Officials

• Michal Mego, PhD, MD

  2nd Department of Oncology, Faculty of Medicine, Comenius University, Bratislava and National Cancer Institute, Bratislava, Slovakia

  PRINCIPAL INVESTIGATOR

• Viktor Bielik, PhD.

  Department of Biological and Medical Sciences, Faculty of Physical Education and Sport, Comenius University in Bratislava, Bratislava, Slovakia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zuzana Orsághová, PhD, MD

CONTACT

+421 2 59378 111; orszaghova.zuzka@gmail.com

Bela Mriňáková, PhD., MD

CONTACT

mrinakova@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 6, 2026
• First Posted: September 14, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: September 14, 2026

Record last verified: 2026-09

Locations

SL (1)