Long-term Evaluation of the Body Composition and the Impact of Resistance and Relaxation Exercise on Muscle Mass and Quality of Life in Patients With Breast Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Change in Skeletal Muscle Mass Index (SMI)
Study Overview
Brief Summary
This observational cohort study aims to track longitudinal changes in body composition, including skeletal muscle mass and fat distribution, in patients diagnosed with breast cancer. Following primary surgery and adjuvant therapy, participants will be monitored over a 2-year period.
The primary objective is to evaluate the natural progression of skeletal muscle mass index (SMI) and metabolic changes in this population. By conducting serial measurements, this study seeks to characterize the longitudinal trends in muscle loss and body composition shifts post-treatment, providing data to better understand the physiological impact of the cancer recovery process.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •>18 years of age
- •Diagnosed with stage I-III non-metastatic breast cancer within 12 months of diagnosis
- •Scheduled for surgery, chemotherapy, with or without radiotherapy or targeted therapy.
Exclusion Criteria
- •Women diagnosed with metastatic (stage IV) breast cancer
- •Women planning to move away from the area or be away for more than 6 months during the study period
- •Women planning to become pregnant during the study period
- •Implantable devices (e.g., pacemaker, nerve stimulator) or surgical implants (e.g., total hip or knee replacements)
Arms & Interventions
Breast Cancer Post-Surgical Cohort
Patients with histologically confirmed Stage I-III non-metastatic breast cancer who have undergone primary surgery and are scheduled to undergo or have completed adjuvant therapy (chemotherapy and/or radiotherapy).
Outcomes
Primary Outcomes
Change in Skeletal Muscle Mass Index (SMI)
Time Frame: Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.
Skeletal Muscle Mass Index (SMI) is the primary metric for assessing muscle mass. It is a composite value calculated by dividing total skeletal muscle mass (kg), as measured by multifrequency bioelectrical impedance analysis (ACCUNIQ BC720; SELVAS Healthcare), by the square of the participant's height (m2). Weight and height are measured at each time point to calculate this single aggregated value (kg/m2). Higher scores indicate greater muscle mass relative to height (better outcome).Unit of Measure: kg/m2
Secondary Outcomes
- Functional Battery: Change from Baseline in Handgrip Strength(Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.)
- Functional Battery: Change from Baseline in 4-Meter Gait Speed(Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.)
- Functional Battery: Change from Baseline in Timed Up & Go (TUG) Test(Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.)
- Functional Battery: Change from Baseline in 30-Second Chair Stand Test(Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.)
- Body Composition: Change from Baseline in Body Fat Mass(Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.)
- Body Composition: Change from Baseline in Arm-to-Leg Lean Mass Ratio(Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.)
- Body Composition: Change from Baseline in Limb-to-Trunk Lean Mass Ratio(Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.)
- Change from Baseline in Overall Edema Index(Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.)
- Change from Baseline in Extracellular Water (ECW)(Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.)
- Change from Baseline in Intracellular Water (ICW)(Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.)