AzTrials
AzTrials

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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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.

Libuša Nechalová, PhD contact

+421940361656

libusa.nechalova@uniba.sk

Viktor Bielik, PhD contact

0948043444

viktor.bielik@uniba.sk

Slovakia1 site, 1 recruiting
  • Comenius University in Bratislava, Faculty of physical education and sport

    Bratislava, 903 01

    Viktor Bielik, PhD, +421948043444, viktor.bielik@uniba.sk

    Recruiting

Other trials in Slovakia

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:

  1. Reductions in body weight, BMI, and fat mass compared to controls.
  2. Improvements in cardiorespiratory fitness and muscle endurance.
  3. Favorable modifications in gut microbiota composition and diversity.
  4. 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.

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 groups in NCT07213271
Study groupRoleWhat they receive
DanceExperimentalThe patients engaged in dance classes two times a week for 3 months
Receives: Other: Dance classes
Patients without organized physical exerciseNo interventionThe 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.

  1. 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

  2. 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

  3. 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)
  1. 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

  2. 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.

  1. First posted8 Oct 2025
  2. Study start1 Mar 2025
  3. Primary completion1 Mar 2026
  4. Study completion31 Dec 2028 (estimated)

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in