Reducing Frailty for Older Cancer Survivors Using Supplements II

• Status: Not yet recruiting
• Trial end date: 2030-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study is a two-arm placebo controlled randomized clinical trial, to assess the effect of a 12-week EGCG intervention on physical frailty compared to placebo in pre-frail older cancer survivors.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rochester
• Treatments: Ascorbic Acid; Epigallocatechin gallate; Vitamins

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 endocrine therapies are allowed to enroll)

4. Have a Fried's Frailty Score (FFS) of ≥ 2

5. Able to provide informed consent, or have consent given by patient-designated health care proxy per institutional policies and University of Rochester Cancer Control URCC guidelines.

Exclusion Criteria:

1. Have chemotherapy planned for the duration of the study.

2. Have abnormal liver function tests (Alanine transaminase (ALT), Aspartate transaminase (AST), and bilirubin ≥ 3 times institutional upper limit of normal) per most recent available lab test (within 3 months of screening).

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) and has no patient-designated health care proxy per institutional policies and University of Rochester Cancer Control University of Rochester Cancer Control (URCC) guidelines.