Longitudinal Body Composition Assessment in Breast Cancer Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorTaipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
>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.
Disqualifiers
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)
Trial population
The study population consists of patients with histologically confirmed primary breast cancer (Stage I-III) recruited from the Department of Breast Surgery/Oncology at the Taipei Buddhist Tzu Chi Hospital. The population includes individuals who have undergone surgical resection and are eligible for, currently receiving, or have recently completed adjuvant therapy (chemotherapy and/or radiotherapy). Patients are tracked through their post-surgical recovery and adjuvant treatment pathways
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 1 trial groupGroup A: Breast Cancer Post-Surgical Cohort
Trial outcomes
Primary outcomes
1
Change in Skeletal Muscle Mass Index (SMI)
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
Time frame
Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.Secondary outcomes
1
Functional Battery: Change from Baseline in Handgrip Strength
Handgrip strength of the dominant hand is measured using a hydraulic dynamometer (LiTE - 200 lb Capacity, USA). Participants perform three trials with a 1-minute rest between attempts; the highest (peak) value of the three trials is recorded. Higher scores indicate greater upper extremity muscle strength (better outcome). Unit of Measure: Kilograms (kg)
Time frame
Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.2
Functional Battery: Change from Baseline in 4-Meter Gait Speed
The 4-meter gait speed (m/s) is measured using a standardized timed walk test. Participants are instructed to walk at their usual pace for 4 meters from a standing start. The time is recorded in seconds and converted to meters per second (m/s). Higher scores indicate faster walking speed (better outcome). Unit of Measure: Meters per second (m/s)
Time frame
Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.3
Functional Battery: Change from Baseline in Timed Up & Go (TUG) Test
Functional mobility and balance are measured using the Timed Up \& Go (TUG) test. The time it takes for a participant to rise from a chair, walk 3 meters, turn around, walk back to the chair, and sit down is recorded. Higher scores (longer time taken) indicate poorer functional mobility and balance (worse outcome). Unit of Measure: Seconds
Time frame
Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.4
Functional Battery: Change from Baseline in 30-Second Chair Stand Test
Lower extremity functional strength is measured as the total number of stands completed in 30 seconds. Participants begin seated and are instructed to stand up and sit down as many times as possible within the 30-second window while keeping their arms crossed over their chest. Higher scores (more stands completed) indicate better lower extremity functional strength and endurance (better outcome). Unit of Measure: Number of stands
Time frame
Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.Sponsors and contacts
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Source ClinicalTrials.gov