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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Valeria Chiu, Attending Physician | Contact | +886266289779 | 67702 | haydenbell28@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation | Recruiting | New Taipei City | Xindian Dist | 231 | Taiwan |
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.
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D055948 | Sarcopenia |
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| 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) | 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 | 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 | 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). | 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 | 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. | 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). | 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. | 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. | Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |