An observational study in Breast Neoplasms, Body Composition and Sarcopenia, sponsored by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation. Recruiting at 1 site in Taiwan. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-16.
Sponsored by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation · Observational
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.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 100 is below the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation is the lead sponsor of 58 studies on the registry; 14 are open to participants now.
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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
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
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.
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.
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.
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.
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.
Body Composition: Change from Baseline in Body Fat Mass
Body fat mass (kg) measured using bioelectrical impedance analysis (ACCUNIQ BC720; SELVAS Healthcare). Higher scores indicate greater absolute body fat (worse outcome).
Time frame: 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
The ratio of total arm lean soft tissue (kg) to total leg lean soft tissue (kg) derived from segmental bioelectrical impedance analysis (ACCUNIQ BC720; SELVAS Healthcare). This ratio is calculated by dividing the sum of lean mass in both arms by the sum of lean mass in both legs. Higher scores indicate a greater proportion of upper limb lean mass relative to lower limb lean mass. Unit of Measure: Ratio
Time frame: 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
The ratio of total limb lean soft tissue (kg) to trunk lean soft tissue (kg) derived from segmental bioelectrical impedance analysis (ACCUNIQ BC720; SELVAS Healthcare). This ratio is calculated by dividing the sum of lean soft tissue from all four limbs by the lean soft tissue of the trunk. Higher scores indicate a greater proportion of appendicular muscle mass relative to the trunk (better outcome). Unit of Measure: Ratio.
Time frame: 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
The Overall Edema Index is calculated as the ratio of Extracellular Water (ECW) to Total Body Water (TBW), as measured by multifrequency bioelectrical impedance analysis (ACCUNIQ BC720; SELVAS Healthcare). This index evaluates systemic fluid distribution and edema progression. Higher scores indicate a higher level of extracellular fluid relative to total body water (worse outcome).
Time frame: 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)
Extracellular Water (ECW) measured in liters via multifrequency bioelectrical impedance analysis (ACCUNIQ BC720; SELVAS Healthcare). Unit of Measure: Liters.
Time frame: 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)
Intracellular Water (ICW) measured in liters via multifrequency bioelectrical impedance analysis (ACCUNIQ BC720; SELVAS Healthcare). Unit of Measure: Liters.
Time frame: Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.
Plan to share: Yes — De-identified individual participant data that underlie the results reported in this article will be available to researchers who provide a methodologically sound proposal. Proposals may be submitted beginning 9 months and ending 36 months following article publication to the corresponding author. Data will be shared after approval of the proposal and the signing of a data access agreement.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
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Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation