Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2025-12-24 @ 3:31 PM
NCT ID:
NCT05535192
Eligibility Criteria:
Inclusion Criteria:
* Women age \>=65
* Diagnosed with stage I-III invasive breast cancer
* BMI between 18-50 kg/m2
* Scheduled to begin at least 10 weeks of neoadjuvant or adjuvant cytotoxic chemotherapy for curative intent
* If enrolled in clinical chemotherapy drug trial, considered eligible if regimen includes an anthracycline or a taxane, unless the trial alters the chemotherapy agents/doses according to patient response (e.g.; I-SPY trials)
* Self-reported ability to walk for 6 minutes and/or 2 blocks (with or without assistive device)
* Ability to provide written informed consent.
* Ability to understand, speak, and read English. This is because many of the study instruments used are not readily available in multiple languages. Additionally, site-based study staff, such as exercise physiologists, are not bilingual and not all sites have access to interpreters.
Exclusion Criteria:
* Following a therapeutic diet for co-morbid disease where the THRIVE-65 diet would be contraindicated as assessed by the RD
* Engaging in 2 or more sessions of strength training exercise per week over a period of at least 3 consecutive months over the past year
* Engaging in aerobic activity at a level that includes competitive events (e.g., marathon, triathlon, running races) over the past year
* Presence of medical conditions or medications that would prohibit participation in an exercise program
* Current use of weight-loss medication
* Documented history of alcohol or substance abuse within the past 12 months
* History of dementia
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
65 Years
Study:
NCT05535192
Study Brief:
Protocol Section:
NCT05535192