Longitudinal Body Composition Assessment in Breast Cancer Patients

Buddhist Tzu Chi Medical Foundation

Status: Enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT07472803

13-IRB110-OBS

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

100 participants in 1 patient group

Breast Cancer Post-Surgical Cohort

Description:

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).