Frailty, Inflammation
Conditions
Brief 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.
Interventions
800mg Epigallocatechin-3-Gallate (EGCG)
800mg microcrystalline cellulose (MCC)
DIETARY_SUPPLEMENTAscorbic Acid (Vitamin C)
250mg Ascorbic Acid (Vitamin C) taken one time daily for 12 weeks
Sponsors
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Patients in the intervention Arm will receive 800 mg Epigallocatechin-3-Gallate (EGCG) + 250mg Ascorbic Acid
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of physical frailty measured using the Short Physical Performance Battery (SPPB) in patients in the EGCG arm compared to placebo; change in SPPB scores from baseline to 12 weeks. | 12 Weeks | We will assess the change in SPPB scores from baseline to 12 weeks after baseline in patients in the EGCG intervention arm compared to the placebo arm. |
Countries
United States
Outcome results
None listed