Reducing Frailty for Older Cancer Survivors Using Supplements

Phase 2

Completed

• Conditions: Frailty; Inflammation
• Interventions: Drug: Epigallocatechin-3-Gallate (EGCG) plus Ascorbic Acid (Vitamin C)

• Registration Number: NCT04553666
• Lead Sponsor: University of Rochester

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-04
• Study First Submitted QC: 2020-09-11
• Study First Posted: 2020-09-17
• Study Start: 2021-03-15
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-19
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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 guidelines.

Exclusion Criteria

Study subjects must not:

1. Have chemotherapy planned for the during of the study.
2. 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).
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 URCC guidelines.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Epigallocatechin-3-Gallate (EGCG) plus Ascorbic Acid (Vitamin C)	Four 200mg EGCG pills and one 250mg Vitamin C pill taken one time each day

Primary Outcome Measures

Name	Time	Method
Recruitment Feasibility: Rates of Consent	Baseline	Recruitment feasibility will be determined by the proportion of participants approached compared to those consented onto the study.
Recruitment Feasibility: Rates of Randomization	Baseline	Recruitment feasibility will be determined by the proportion of participants consented compared to those randomized into one of the study arms.
The Proportion of Participants That Completed the Study	12 week	To determine adherence of a two arm randomized clinical trial of EGCG supplementation in older survivors of cancer by determining how many participants completed the study.The number of participants randomized compared to the number of participants that returned for the post intervention visit.
The Proportion of Participants That Were Adherent to the Intervention	12 week	To determine adherence of a two arm randomized clinical trial of EGCG supplementation in older survivors of cancer by determining the proportion of participants that were adherent to the intervention (taking \>70% of study drug).
Safety of the EGCG Intervention	12 weeks	Total (sum) and severity of adverse events (AEs) reported over 12 weeks of being on study graded using CTCAE v5.0 was determined. Participants were called weekly by study coordinator and asked to report concerns including: symptoms, signs, illnesses, or experiences that develop or worsen during the study. These concerns were graded according to the CTCAE v5.0. Number of participants who reported any AEs during the 12 weeks of the study are reported.

Trial Locations

Locations (1)

University of Rochester; 🇺🇸 Rochester, New York, United States