Improving physical health in older cancer survivors with supplements
A Phase 2 Randomized Controlled Trial of Epigallocatechin-3-Gallate (EGCG) on Frailty and Inflammation in Older Survivors of Cancer
This study is testing if a natural supplement can help older cancer survivors feel stronger and healthier over 12 weeks.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 118 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | University of Rochester Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Rochester, New York) |
| Trial ID | NCT06068543 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the impact of a 12-week intervention using Epigallocatechin-3-Gallate (EGCG) on reducing physical frailty in pre-frail older adults who have survived cancer. Participants will be randomly assigned to receive either the EGCG supplement or a placebo, allowing researchers to compare the effects on frailty levels. The study aims to determine if this natural compound can enhance physical resilience and overall health in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 65 and older who have been diagnosed with stage I-III cancer and have completed curative treatment within the last 10 years.
Not a fit: Patients currently undergoing chemotherapy or systemic cancer treatment, or those with significant liver issues, will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the physical health and quality of life for older cancer survivors experiencing frailty.
How similar studies have performed: While there is ongoing research into the effects of EGCG on health, this specific approach targeting frailty in older cancer survivors is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Be age 65 or over. 2. Be diagnosed with stage I-III Cancer 3. Have completed curative intent treatment ≤10 years prior to screening Patients on the following endocrine therapies are allowed to enroll (Anastrozole,Leuprolide acetate, and Bicalutamide) 4. Have a Fried's Frailty Score (FFS) of ≥ 1 5. Able to provide informed consent Exclusion Criteria: 1. Have chemotherapy or other systemic cancer treatment planned to occur during the study period. 2. Have abnormal liver function tests (ALT, AST, and bilirubin) per most recent available lab test (within 3 months of screening) * 3 times institutional upper limit of normal for ALT and AST * 1.5 times institutional upper limit of normal for bilirubin 3. Have uncontrolled or unmanaged liver disease. 4. Consume more than 6 cups of green tea per day. 5. Have known allergies to caffeine. 6. Be diagnosed with a major psychiatric illness requiring hospitalization within the last year. 7. Be diagnosed with dementia. 8. Cannot provide informed consent due to lack of decision-making capacity (as determined by the patient's oncologist).
Where this trial is running
Rochester, New York
- University of Rochester — Rochester, New York, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.