Clinical trial

Physical Exercise on Metabolic Health, Gut Microbiota, Physical Fitness, and Quality of Life in Obese Breast Cancer Survivors

Recruiting now · Not applicable · 1 countries · Registry ID NCT07213271

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age25 Years to 70 Years

SexFemale

Healthy volunteersAccepted

ConditionBreast Cancer Females

Full registry criteria

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

Treatments and study arms

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

Gut Microbiota Composition (alpha and beta diversity indices)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 measuresBaseline 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 assesmentBaseline 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.

Study locations

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Comenius University in Bratislava, Faculty of physical education and sport🌐 Bratislava, Slovakia

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Viktor Bielik, PhDContact

Email · Call +421948043444