Reducing Frailty for Older Cancer Survivors Using Supplements

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to to obtain preliminary data on the effects of twelve weeks oral supplementation of Epigallocatechin-3-gallate (EGCG) on frailty and inflammation in older survivors of colon cancer

• 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 Colon Cancer

3. Have completed cancer treatment for CC ≤6 months prior to screening (i.e. ≤6 months from surgery if received surgery alone without chemo or ≤ 6 months from completion of chemotherapy).

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 guidelines.

Exclusion Criteria:Study subjects must not:

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

2. Have abnormal liver function tests (ALT and AST 1.5 times institutional upper limit of normal) per most recent available lab test (within 1 month of screening).

3. Have uncontrolled or unmanaged liver disease.

4. Consume more than 6 cups of green tea per day.

5. Have an Ileostomy.

6. Have known allergies to caffeine.

7. Be diagnosed with a major psychiatric illness requiring hospitalization within the last year.

8. Be diagnosed with dementia.

9. 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 URCC guidelines