Longitudinal Body Composition Assessment in Breast Cancer Patients (NCT07472803) | Clinical Trial Compass
RecruitingNot Applicable
Longitudinal Body Composition Assessment in Breast Cancer Patients
Taiwan100 participantsStarted 2025-05-19
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Skeletal Muscle Mass Index (SMI)
Timeframe: Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.
Trial details
NCT IDNCT07472803
SponsorTaipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation