Breast Cancer FemalesOBINTNCT07213271
Physical Exercise on Metabolic Health, Gut Microbiota, Physical Fitness, and Quality of Life in Obese Breast Cancer Survivors
A study testing Dance classes in people with Breast Cancer Females, run by Comenius University at 1 site in Slovakia.
Trial summary
The goal of this clinical trial is to evaluate whether a 3-month dance-based exercise program combined with individualized nutrition can improve health outcomes in obese breast cancer survivors in remission. Read more about this study
- Who is it for?
- Ages 25 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Females
- What is being tested?
- Dance classes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSlovakia
- Study dates
- 1 Mar 2025to 31 Dec 2028
- 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 25 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of breast cancer disease
- At least one year after breast cancer treatment
- Must be able to swallow tablets
- Must be able to folow physical exercise training
Who cannot join
- Clinical diagnosis of Parkinson's disease
- Insulin dependent diabetes
- Infectious diseases within the past 2 months
- Use of antibiotics within the past 4 weeks before recruitment
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, 1 recruiting
- Recruiting
Comenius University in Bratislava, Faculty of physical education and sport
Bratislava, 903 01
Viktor Bielik, PhD, +421948043444, viktor.bielik@uniba.sk
About this study
Official title: The Impact of Dance Intervention on Metabolic Health, Gut Microbiota, Physical Fitness, and Quality of Life in Obese Breast Cancer Survivors
The goal of this clinical trial is to evaluate whether a 3-month dance-based exercise program combined with individualized nutrition can improve health outcomes in obese breast cancer survivors in remission. The main questions it aims to answer are:
Will the intervention reduce body weight, body fat, and visceral adiposity?
Read more
Will it improve cardiorespiratory fitness, motor performance, gut microbiota composition, and quality of life?
Researchers will compare women participating in the dance and nutrition program with a control group who maintain their usual lifestyle to see if the intervention leads to favorable metabolic, physical, and microbiome-related changes.
Participants will:
Attend supervised dance classes three times per week for 12 weeks.
Follow an individualized nutrition plan tailored to their resting metabolic rate.
Provide blood and stool samples, complete fitness tests, and answer quality-of-life questionnaires before and after the intervention.
Read the detailed description
Breast cancer is one of the most prevalent cancers worldwide and its survivors frequently face long-term challenges even after successful treatment. Obesity is a well-established risk factor for both the development and recurrence of breast cancer, and it often worsens treatment-related side effects. Furthermore, increasing evidence suggests that obesity and breast cancer therapies can disrupt the gut microbiota, which may contribute to metabolic complications, systemic inflammation, impaired immunity, and reduced quality of life. Effective, non-pharmacological strategies that simultaneously target metabolic health, microbiome recovery, and physical function are needed for this growing patient population.
The present randomized controlled trial has been designed to examine whether a dance-based physical activity intervention combined with individualized nutrition can favorably influence metabolic health, gut microbiota composition, physical fitness, and quality of life in obese breast cancer survivors in remission. Dance was chosen as the primary exercise modality because it integrates aerobic, strength, and motor-coordination elements in an engaging and culturally adaptable format that may enhance adherence compared to conventional exercise programs.
A total of approximately 40 women with a history of breast cancer, currently in remission and classified as obese, will be recruited and randomized into two groups: an intervention group and a control group. The intervention group will participate in supervised dance sessions three times per week, each lasting 60 minutes, for a total of 12 weeks. Classes will be delivered by certified professional instructors and will include choreographies from folkloric, Latin American, and contemporary dance. To further support metabolic improvements, participants in this group will also receive a personalized dietary plan generated using specialized software, prescribing an energy intake of 1200-1500 kcal/day with balanced proportions of carbohydrates (30-50%), fats (25-30%), proteins (20-30%), and fiber (14 g/1000 kcal). The control group will be instructed to continue their usual daily routines and refrain from initiating new structured physical activities during the study period.
Before and after the intervention, all participants will undergo comprehensive evaluations, including:
- Anthropometry and body composition (weight, BMI, fat mass, visceral fat, waist-hip ratio, muscle mass, resting metabolic rate) using validated bioimpedance and anthropometric methods.
- Physical fitness testing, including a maximal cardiopulmonary exercise test on a cycle ergometer to determine VO₂max, ventilatory parameters, and workload capacity, along with motor performance assessments (handgrip strength, 30-second chair stand, and 30-second arm curl tests).
- Biochemical analysis, including fasting glucose, insulin, lipid profile, liver enzymes, and insulin resistance index (HOMA-IR).
- Gut permeability assessment through serum zonulin measurements.
- Gut microbiota profiling using 16S rRNA sequencing of fecal samples, with alpha and beta diversity indices and taxonomic composition analyses.
- Dietary intake assessed by 3-day food diaries analyzed for caloric and nutrient content.
- Quality of life measured using the EORTC QLQ-C30 and the breast cancer-specific BR23 questionnaire.
The primary outcomes of interest will be changes in body composition (weight, BMI, fat and visceral adiposity) and cardiorespiratory fitness (VO₂max). Secondary outcomes include alterations in gut microbiota diversity and community structure, gut permeability, metabolic biomarkers, dietary patterns, motor performance, and quality-of-life scores. It is hypothesized that obese breast cancer survivors participating in the dance and nutrition program will show:
- Reductions in body weight, BMI, and fat mass compared to controls.
- Improvements in cardiorespiratory fitness and muscle endurance.
- Favorable modifications in gut microbiota composition and diversity.
- Enhanced quality of life, particularly in physical, emotional, and social domains.
The findings of this study are expected to contribute to a deeper understanding of the role of structured physical activity and diet in post-cancer recovery. Specifically, this trial will provide novel evidence on how a culturally engaging, sustainable, and enjoyable form of exercise - dance - combined with individualized nutrition may promote metabolic health, microbiome restoration, and long-term well-being in obese breast cancer survivors. If effective, this intervention model could be implemented in rehabilitation programs and community health settings to support survivorship care and reduce the risk of cancer recurrence and comorbidities.
- Conditions
- Breast Cancer Females
- Being tested
- Dance classes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dance classesOther
Participants will attend supervised sessions three times per week, each lasting 60 minutes. Classes were instructed by certified professional dancers and incorporated structured choreographies from three dance genres: folkloric, Latin American, and contemporary.
| Study group | Role | What they receive |
|---|---|---|
| Dance | Experimental | The patients engaged in dance classes two times a week for 3 months Receives: Other: Dance classes |
| Patients without organized physical exercise | No intervention | The patients engaged in no structured or self-induced physical exercise or activity (sedentary individuals) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut Microbiota Composition (alpha and beta diversity indices)
Evaluated using 16S rRNA sequencing of fecal samples; primary indices include Shannon diversity, Chao1 richness, and Bray-Curtis dissimilarity
Measured: Baseline to 12 weeks
Metabolite outcome measures
Systemic inflammation and gut-related metabolites will be assessed by measuring blood biomarkers (hs-CRP, IL-6, TNF-α), fecal inflammatory markers (calprotectin, lactoferrin), and microbiota-derived metabolites including short-chain fatty acids (acetate, propionate, butyrate) in feces and plasma, as well as plasma metabolites such as TMAO and selected bile acids. Intestinal permeability will be evaluated through serum zonulin levels. Together, these measures will provide an integrated view of inflammatory status, microbial metabolic activity, and gut barrier function.
Measured: Baseline to 12 weeks
Quality of Life assesment
Change in Quality of Life (EORTC QLQ-C30 Global Health Score) measured using the EORTC QLQ-C30 questionnaire (version 3.0), with scores transformed to a 0-100 scale according to the scoring manual.
Measured: Baseline to 12 weeks
Secondary outcomes (2)
Cardiorespiratory Fitness
Change in Cardiorespiratory Fitness (VO₂max, ml/min/kg) determined by incremental cardiopulmonary exercise testing on a cycle ergometer to evaluate aerobic capacity.
Measured: Baseline to 12 weeks
Body composition
Change in Fat Mass and Visceral Adiposity measured by bioimpedance (InBody 230 device) to assess reduction in total fat mass and visceral fat levels.
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start1 Mar 2025
- Primary completion1 Mar 2026
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemalesStudies 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
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Comenius University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Viktor Bielik, Comenius University
- Investigators
- Viktor Bielik, PhD, Principal investigator, Comenius University, Faculty of Physical Education and Sport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07213271
- Sponsor's protocol ID
- APVV-22-0047
- Acronym
- OBINT
- Status last verified
- Jul 2026
- First submitted
- 22 Sep 2025
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nechalova L, Penesova A, Hric I, Olej P, Simiakova M, Ugrayova S, Hekkala J, Kelcikova S, Grendar M, Pekkala S, Bielik V. Dance and Dietary Intervention Improves Metabolic Health, Fitness, and Quality of Life With Modest Gut Microbiota Shifts in Breast Cancer Patients With Obesity: A Pilot RCT. Cancer Rep (Hoboken). 2026 Jun;9(6):e70611. doi: 10.1002/cnr2.70611.
PubMed 42321999
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Dance Intervention on Metabolic Health, Gut Microbiota, Physical Fitness, and Quality of Life in Obese Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT07213271
- Acronym / sponsor ID
- OBINT / APVV-22-0047
- Conditions
- Breast Cancer Females
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Comenius UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 8 Oct 2025 (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 evaluate whether a 3-month dance-based exercise program combined with individualized nutrition can improve health outcomes in obese breast cancer survivors in remission. The main questions it aims to answer are:
Will the intervention reduce body weight, body fat, and visceral adiposity?
Will it improve cardiorespiratory fitness, motor performance, gut microbiota composition, and quality of life?
Researchers will compare women participating in the dance and nutrition program with a control group who maintain their usual lifestyle to see if the intervention leads to favorable metabolic, physical, and microbiome-related changes.
Participants will:
Attend supervised dance classes three times per week for 12 weeks.
Follow an individualized nutrition plan tailored to their resting metabolic rate.
Provide blood and stool samples, complete fitness tests, and answer quality-of-life questionnaires before and after the intervention.
Detailed description
Breast cancer is one of the most prevalent cancers worldwide and its survivors frequently face long-term challenges even after successful treatment. Obesity is a well-established risk factor for both the development and recurrence of breast cancer, and it often worsens treatment-related side effects. Furthermore, increasing evidence suggests that obesity and breast cancer therapies can disrupt the gut microbiota, which may contribute to metabolic complications, systemic inflammation, impaired immunity, and reduced quality of life. Effective, non-pharmacological strategies that simultaneously target metabolic health, microbiome recovery, and physical function are needed for this growing patient population.
The present randomized controlled trial has been designed to examine whether a dance-based physical activity intervention combined with individualized nutrition can favorably influence metabolic health, gut microbiota composition, physical fitness, and quality of life in obese breast cancer survivors in remission. Dance was chosen as the primary exercise modality because it integrates aerobic, strength, and motor-coordination elements in an engaging and culturally adaptable format that may enhance adherence compared to conventional exercise programs.
A total of approximately 40 women with a history of breast cancer, currently in remission and classified as obese, will be recruited and randomized into two groups: an intervention group and a control group. The intervention group will participate in supervised dance sessions three times per week, each lasting 60 minutes, for a total of 12 weeks. Classes will be delivered by certified professional instructors and will include choreographies from folkloric, Latin American, and contemporary dance. To further support metabolic improvements, participants in this group will also receive a personalized dietary plan generated using specialized software, prescribing an energy intake of 1200-1500 kcal/day with balanced proportions of carbohydrates (30-50%), fats (25-30%), proteins (20-30%), and fiber (14 g/1000 kcal). The control group will be instructed to continue their usual daily routines and refrain from initiating new structured physical activities during the study period.
Before and after the intervention, all participants will undergo comprehensive evaluations, including:
- Anthropometry and body composition (weight, BMI, fat mass, visceral fat, waist-hip ratio, muscle mass, resting metabolic rate) using validated bioimpedance and anthropometric methods.
- Physical fitness testing, including a maximal cardiopulmonary exercise test on a cycle ergometer to determine VO₂max, ventilatory parameters, and workload capacity, along with motor performance assessments (handgrip strength, 30-second chair stand, and 30-second arm curl tests).
- Biochemical analysis, including fasting glucose, insulin, lipid profile, liver enzymes, and insulin resistance index (HOMA-IR).
- Gut permeability assessment through serum zonulin measurements.
- Gut microbiota profiling using 16S rRNA sequencing of fecal samples, with alpha and beta diversity indices and taxonomic composition analyses.
- Dietary intake assessed by 3-day food diaries analyzed for caloric and nutrient content.
- Quality of life measured using the EORTC QLQ-C30 and the breast cancer-specific BR23 questionnaire.
The primary outcomes of interest will be changes in body composition (weight, BMI, fat and visceral adiposity) and cardiorespiratory fitness (VO₂max). Secondary outcomes include alterations in gut microbiota diversity and community structure, gut permeability, metabolic biomarkers, dietary patterns, motor performance, and quality-of-life scores. It is hypothesized that obese breast cancer survivors participating in the dance and nutrition program will show:
- Reductions in body weight, BMI, and fat mass compared to controls.
- Improvements in cardiorespiratory fitness and muscle endurance.
- Favorable modifications in gut microbiota composition and diversity.
- Enhanced quality of life, particularly in physical, emotional, and social domains.
The findings of this study are expected to contribute to a deeper understanding of the role of structured physical activity and diet in post-cancer recovery. Specifically, this trial will provide novel evidence on how a culturally engaging, sustainable, and enjoyable form of exercise - dance - combined with individualized nutrition may promote metabolic health, microbiome restoration, and long-term well-being in obese breast cancer survivors. If effective, this intervention model could be implemented in rehabilitation programs and community health settings to support survivorship care and reduce the risk of cancer recurrence and comorbidities.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dance | Experimental | Other: Dance classesThe patients engaged in dance classes two times a week for 3 months |
| Patients without organized physical exercise | No intervention | –The patients engaged in no structured or self-induced physical exercise or activity (sedentary individuals) |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of breast cancer disease
- At least one year after breast cancer treatment
- Must be able to swallow tablets
- Must be able to folow physical exercise training
Key exclusion criteria (4 listed)
- Clinical diagnosis of Parkinson's disease
- Insulin dependent diabetes
- Infectious diseases within the past 2 months
- Use of antibiotics within the past 4 weeks before recruitment
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 classesParticipants will attend supervised sessions three times per week, each lasting 60 minutes. Classes were instructed by certified professional dancers and incorporated structured choreographies from three dance genres: folkloric, Latin American, and contemporary. | Other | Dance |
Primary outcome
Gut Microbiota Composition (alpha and beta diversity indices)
Time frame: Baseline to 12 weeks
Evaluated using 16S rRNA sequencing of fecal samples; primary indices include Shannon diversity, Chao1 richness, and Bray-Curtis dissimilarity
Metabolite outcome measures
Time frame: Baseline to 12 weeks
Systemic inflammation and gut-related metabolites will be assessed by measuring blood biomarkers (hs-CRP, IL-6, TNF-α), fecal inflammatory markers (calprotectin, lactoferrin), and microbiota-derived metabolites including short-chain fatty acids (acetate, propionate, butyrate) in feces and plasma, as well as plasma metabolites such as TMAO and selected bile acids. Intestinal permeability will be evaluated through serum zonulin levels. Together, these measures will provide an integrated view of inflammatory status, microbial metabolic activity, and gut barrier function.
Quality of Life assesment
Time frame: Baseline to 12 weeks
Change in Quality of Life (EORTC QLQ-C30 Global Health Score) measured using the EORTC QLQ-C30 questionnaire (version 3.0), with scores transformed to a 0-100 scale according to the scoring manual.
2 secondary outcomes
Cardiorespiratory Fitness
Time frame: Baseline to 12 weeks
Body composition
Time frame: Baseline to 12 weeks
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 23 Jul 2026.
- Derived from this study: PubMed 42321999Nechalova L, Penesova A, Hric I, Olej P, Simiakova M, Ugrayova S, Hekkala J, Kelcikova S, Grendar M, Pekkala S, Bielik V. Dance and Dietary Intervention Improves Metabolic Health, Fitness, and Quality of Life With Modest Gut Microbiota Shifts in Breast Cancer Patients With Obesity: A Pilot RCT. Cancer Rep (Hoboken). 2026 Jun;9(6):e70611. doi: 10.1002/cnr2.70611.
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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.
Viktor Bielik, PhD principal investigator
Comenius University, Faculty of Physical Education and Sport
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 classes in people with Breast Cancer Females, 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 23 Jul 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?
Contact Libuša Nechalová, PhD (+421940361656, libusa.nechalova@uniba.sk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut Microbiota Composition (alpha and beta diversity indices) (time frame: Baseline to 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07213271, which also lists 1 linked publication.
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 23 Jul 2026.