Longitudinal Body Composition Assessment in Breast Cancer Patients

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

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 Overview

• Status: Recruiting
• Conditions: Breast Neoplasms; Lymphedema; Body Composition; Sarcopenia; Fat Redistribution

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Valeria Chiu, Attending Physician; Phone Number: 67702 +886266289779; Email: haydenbell28@gmail.com

Study Locations

• Taiwan
  • Xindian Dist
    • New Taipei City, Xindian Dist, Taiwan, 231
      • Recruiting
      • Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
      • Contact: Taipei Tzu Chi Hospital; Phone Number: 5706 +886266289779; Email: xdirb@tzuchi.com.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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)	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.

Collaborators and Investigators

• Sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: March 7, 2026
• First Submitted That Met QC Criteria: March 12, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Body Composition; sarcopenia; Breast Cancer Survivors; Metabolic Monitoring; Post-Treatment Recovery; Longitudinal Cohort Study; Skeletal Muscle Mass Index
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Neoplasms by Site; Neoplasms; Pathological Conditions, Anatomical; Skin Diseases; Breast Diseases; Lymphatic Diseases; Muscular Atrophy; Atrophy; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Signs and Symptoms; Hemic and Lymphatic Diseases; Breast Neoplasms; Lymphedema; Sarcopenia
• Other Study ID Numbers: 13-IRB110-OBS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No