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NCT Number: NCT07213271

Physical Exercise 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?

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.

Recruiting

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Key information

Age range

25 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Comenius University in Bratislava, Faculty of physical education and sport

Bratislava, 903 01, Slovakia

Location status: Recruiting

Location contact

Viktor Bielik, PhD

CONTACT

[email protected]

+421948043444

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Dance classes

Other

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.

Primary outcomes

  1. 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

  2. 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.

  3. 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.

Secondary outcomes

  1. Cardiorespiratory Fitness

    Time frame: Baseline to 12 weeks

    Change in Cardiorespiratory Fitness (VO₂max, ml/min/kg) determined by incremental cardiopulmonary exercise testing on a cycle ergometer to evaluate aerobic capacity.

  2. Body composition

    Time frame: Baseline to 12 weeks

    Change in Fat Mass and Visceral Adiposity measured by bioimpedance (InBody 230 device) to assess reduction in total fat mass and visceral fat levels.

Study contacts

Contact information is provided by the study sponsor or research team.

Libuša Nechalová, PhD

CONTACT

[email protected]

+421940361656

Viktor Bielik, PhD

CONTACT

[email protected]

0948043444

Sponsors and collaborators

Lead sponsor

Comenius University

Other

Registry information

Official study title

The Impact of Dance Intervention on Metabolic Health, Gut Microbiota, Physical Fitness, and Quality of Life in Obese Breast Cancer Survivors

Acronym: OBINT

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Oct 8, 2025
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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