Longitudinal Body Composition Assessment in Breast Cancer Patients

NCT07472803 | Recruiting

• 1 other identifier: 13-IRB110-OBS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms; Body Composition; Sarcopenia; Fat Redistribution; Lymphedema

Keywords

Breast Cancer Survivors; Post-Treatment Recovery; Body Composition; Longitudinal Cohort Study; Skeletal Muscle Mass Index; Metabolic Monitoring; sarcopenia

Outcome Measures

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

  Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.

Secondary Outcomes (10)

• 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.

Study Arms (1)

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• \>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.

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

New Taipei City, Xindian Dist, 231, Taiwan

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Sarcopenia; Lymphedema

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Lymphatic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Valeria Chiu, Attending Physician

CONTACT

+886266289779; haydenbell28@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2026
• First Posted: March 16, 2026
• Study Start: May 19, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

TW (1)