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

NCT07213271 | Active Not Recruiting

• 1 other identifier: APVV-22-0047
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Breast Cancer Females

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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.

  Baseline to 12 weeks

Secondary Outcomes (2)

• Cardiorespiratory Fitness

  Baseline to 12 weeks

• Body composition

  Baseline to 12 weeks

Study Arms (2)

Dance

EXPERIMENTAL

The patients engaged in dance classes two times a week for 3 months

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)

Interventions

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.

Dance

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Comenius University: lead

Study Sites (1)

Comenius University in Bratislava, Faculty of physical education and sport

Bratislava, 903 01, Slovakia

Location

Study Officials

• Viktor Bielik, PhD

  Comenius University, Faculty of Physical Education and Sport

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: October 8, 2025
• Study Start: March 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

SL (1)