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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25-70
SponsorComenius University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Dance classes

    Other intervention

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: DanceExperimental treatment 1 intervention
Group B: Patients without organized physical exerciseNo intervention 0 interventions

Trial outcomes

Primary outcomes

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

Time frame
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.

Time frame
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.

Time frame
Baseline to 12 weeks

Secondary outcomes

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.

Time frame
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.

Time frame
Baseline to 12 weeks

Other outcomes

Sponsors and contacts

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