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Recruiting NCT07472803

Longitudinal Body Composition Assessment in Breast Cancer Patients

— Observational Breast Neoplasms Body Composition Sarcopenia Fat Redistribution

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Breast Neoplasms, Body Composition, Sarcopenia, Fat Redistribution. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Primary outcome measures

  • Change in Skeletal Muscle Mass Index (SMI) [Time frame: Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.]
Secondary outcome measures (10)
  • Functional Battery: Change from Baseline in Handgrip Strength [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 [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 [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 [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 [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 [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 [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 [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) [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) [Time frame: Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Taiwan · 1 center
  • Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation — New Taipei City

Identifiers

NCT: NCT07472803 · 13-IRB110-OBS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗