An interventional study of Dance-Based Exercise Program in Breast Neoplasms, sponsored by Comenius University. Enrolling by invitation at 1 site in Slovakia. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Comenius University · Not applicable, Interventional, and Supportive care
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.
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.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 104 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Comenius University is the lead sponsor of 42 studies on the registry; 11 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Signed and dated written . Female patients with confirmed, newly diagnosed, non- invasive breast cancer.
Age 18-60 years. (BMI) \<35 kg/m². Indication for and planned initiation of 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.
(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:
breast cancer at the time of study enrollment. Recurrent breast cancer or previous treatment for the current breast cancer, except for diagnostic and other diagnostic procedures.
Previous invasive 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.
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.
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 or reliable completion of study assessments.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive standard neoadjuvant oncological treatment and participate in a supervised 12-week dance-based exercise program.
Other: Dance-Based Exercise Program
Participants receive standard neoadjuvant oncological treatment without participation in the structured dance-based exercise program.
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.
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 intervention
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 intervention
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 intervention
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 intervention
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 intervention
Change in Inflammatory Biomarkers
Blood samples will be analyzed for selected circulating biomarkers related to systemic inflammation. Changes in biomarker concentrations from baseline will be evaluated.
Time frame: Baseline to the end of the 12-week intervention
Change in Markers of Intestinal Permeability
Blood samples will be analyzed for selected biomarkers related to intestinal barrier function and permeability. Changes from baseline will be evaluated.
Time frame: Baseline to the end of the 12-week intervention
Long-Term Cancer-Related Fatigue
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.
Time frame: Approximately 90, 180, and 365 days after surgery
Long-Term Quality of Life
Quality of life will be reassessed during postoperative follow-up using the study-specified validated questionnaire to evaluate longer-term differences between groups.
Time frame: Approximately 90, 180, and 365 days after surgery
Plan to share: Undecided
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Dec 2029, 39 months after the start.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 39 months is above that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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