Breast NeoplasmsDANCE-BCNCT07817355
Dance-Based Exercise for Cancer-Related Fatigue in Breast Cancer Patients
A study testing Dance-Based Exercise Program in people with Breast Neoplasms, run by Comenius University at 1 site in Slovakia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Dance-Based Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteSlovakia
- Study dates
- 1 Sep 2026to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovakia1 site
2nd Department of Oncology, Faculty of Medicine, Comenius University and National Cancer Institute
Bratislava, 83310
About this study
Official title: The Effect of a Dance-Based Exercise Intervention on Cancer-Related Fatigue in Breast Cancer Patients Undergoing Neoadjuvant Treatment: A Randomized Controlled Study.
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?
Read more
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.
Read the 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.
- Conditions
- Breast Neoplasms
- Being tested
- Dance-Based Exercise Program
- Keywords
- Physical Exercise, Breast Cancer, Quality of Life, Gut Microbiome, Dance
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dance-Based Exercise ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Dance-Based Exercise Intervention | Experimental | Participants receive standard neoadjuvant oncological treatment and participate in a supervised 12-week dance-based exercise program. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to the end of the 12-week intervention
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Approximately 90, 180, and 365 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start1 Sep 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Comenius University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michal Mego, PhD, MD, Principal investigator, 2nd Department of Oncology, Faculty of Medicine, Comenius University, Bratislava and National Cancer Institute, Bratislava, SlovakiaViktor Bielik, PhD., Principal investigator, Department of Biological and Medical Sciences, Faculty of Physical Education and Sport, Comenius University in Bratislava, Bratislava, Slovakia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07817355
- Sponsor's protocol ID
- 1/0437/27
- Acronym
- DANCE-BC
- Status last verified
- Nov 2026
- First submitted
- 6 Sep 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Dance-Based Exercise Intervention on Cancer-Related Fatigue in Breast Cancer Patients Undergoing Neoadjuvant Treatment: A Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT07817355
- Acronym / sponsor ID
- DANCE-BC / 1/0437/27
- Conditions
- Breast Neoplasms
- Keywords
- Physical Exercise, Breast Cancer, Quality of Life, Gut Microbiome, Dance
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Comenius UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dance-Based Exercise Intervention | Experimental | Other: Dance-Based Exercise ProgramParticipants receive standard neoadjuvant oncological treatment and participate in a supervised 12-week dance-based exercise program. |
| Standard Care Control | No intervention | –Participants receive standard neoadjuvant oncological treatment without participation in the structured dance-based exercise program. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dance-Based Exercise ProgramParticipants 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. | Other | Dance-Based Exercise Intervention |
Primary outcome
Change in Cancer-Related Fatigue Assessed by the FACIT-Fatigue Scale
Time frame: 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.
8 secondary outcomes
Change in Quality of Life
Time frame: Baseline to the end of the 12-week intervention
Change in Cardiorespiratory Fitness
Time frame: Baseline to the end of the 12-week intervention
Change in Lower and Upper-Body Muscular Strength
Time frame: Baseline to the end of the 12-week intervention
Change in Gut Microbiome Diversity and Composition
Time frame: Baseline to the end of the 12-week intervention
Change in Inflammatory Biomarkers
Time frame: Baseline to the end of the 12-week intervention
Change in Markers of Intestinal Permeability
Time frame: Baseline to the end of the 12-week intervention
Long-Term Cancer-Related Fatigue
Time frame: Approximately 90, 180, and 365 days after surgery
Long-Term Quality of Life
Time frame: Approximately 90, 180, and 365 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michal Mego, PhD, MD principal investigator
2nd Department of Oncology, Faculty of Medicine, Comenius University, Bratislava and National Cancer Institute, Bratislava, Slovakia
Viktor Bielik, PhD. principal investigator
Department of Biological and Medical Sciences, Faculty of Physical Education and Sport, Comenius University in Bratislava, Bratislava, Slovakia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dance-Based Exercise Program in people with Breast Neoplasms, run by Comenius University at 1 site in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cancer-Related Fatigue Assessed by the FACIT-Fatigue Scale (time frame: Baseline to the end of the 12-week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.