Phase 2
N=14
Reducing Frailty for Older Cancer Survivors Using Supplements
Frailty · Inflammation
Bottom Line
View on ClinicalTrials.gov: NCT04553666 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Recruitment Feasibility: Rates of Consent — 0.375 proportion of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Epigallocatechin-3-Gallate (EGCG) plus Ascorbic Acid (Vitamin C) (Drug)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- University of Rochester
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recruitment Feasibility: Rates of Consent |
0.375 | — |
| PRIMARY Recruitment Feasibility: Rates of Randomization |
0.583 | — |
| PRIMARY The Proportion of Participants That Completed the Study |
1; 1 | — |
| PRIMARY The Proportion of Participants That Were Adherent to the Intervention |
0.857 | — |
| PRIMARY Safety of the EGCG Intervention |
2; 0; 1; 0; 1; 0 | — |
Summary
The purpose of the study is to examine the feasibility and safety of twelve weeks oral supplementation of Epigallocatechin-3-gallate (EGCG) in older survivors of cancer
Eligibility Criteria
Inclusion Criteria
- Be age 65 or over.
- Be diagnosed with stage I-III Cancer.
- Have completed curative intent treatment ≤10 years prior to screening. (Patients on endocrine therapies are allowed to enroll.)
- Have a Fried's Frailty Score (FFS) of ≥ 2.
- 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:
- Have chemotherapy planned for the during of the study.
- Have abnormal liver function tests (ALT, AST and bilirubin ≥3 times institutional upper limit of normal) per most recent available lab test (within 3 months of screening).
- Have uncontrolled or unmanaged liver disease.
- Consume more than 6 cups of green tea per day.
- Have known allergies to caffeine.
- Be diagnosed with a major psychiatric illness requiring hospitalization within the last year.
- Be diagnosed with dementia.
- 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.
Data sourced from ClinicalTrials.gov (NCT04553666). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.