To hear about similar clinical trials, please enter your email below
Trial Title:
Reducing Frailty for Older Cancer Survivors Using Supplements II
NCT ID:
NCT06068543
Condition:
Frailty
Inflammation
Conditions: Official terms:
Inflammation
Frailty
Vitamins
Ascorbic Acid
Epigallocatechin gallate
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Patients in the intervention Arm will receive 800 mg Epigallocatechin-3-Gallate (EGCG) +
250mg Ascorbic Acid
Primary purpose:
Supportive Care
Masking:
Triple (Participant, Care Provider, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
Epigallocatechin-3-Gallate (EGCG)
Description:
800mg Epigallocatechin-3-Gallate (EGCG)
Arm group label:
Epigallocatechin-3-Gallate (EGCG)
Other name:
EGCG
Intervention type:
Drug
Intervention name:
Microcrystalline cellulose (MCC)
Description:
800mg microcrystalline cellulose (MCC)
Arm group label:
Microcrystalline cellulose (MCC)
Other name:
MCC
Intervention type:
Dietary Supplement
Intervention name:
Ascorbic Acid (Vitamin C)
Description:
250mg Ascorbic Acid (Vitamin C) taken one time daily for 12 weeks
Arm group label:
Epigallocatechin-3-Gallate (EGCG)
Arm group label:
Microcrystalline cellulose (MCC)
Other name:
Vitamin C
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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
65 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Rochester
Address:
City:
Rochester
Zip:
14627
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nikesha Gilmore, PhD
Phone:
585-275-1275
Email:
nikesha_gilmore@urmc.rochester.edu
Start date:
June 28, 2024
Completion date:
December 31, 2030
Lead sponsor:
Agency:
University of Rochester
Agency class:
Other
Source:
University of Rochester
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06068543
