CompletedPhase 2

Reducing Frailty for Older Cancer Survivors Using Supplements

United States24 participantsStarted 2021-04-28

Plain-language 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

Who can participate

Age range65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

✕. 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.

What they're measuring

Recruitment Feasibility: Rates of Consent

Timeframe: Baseline

Recruitment Feasibility: Rates of Randomization

Timeframe: Baseline

The Proportion of Participants That Completed the Study

Timeframe: 12 week

The Proportion of Participants That Were Adherent to the Intervention

Timeframe: 12 week

Safety of the EGCG Intervention

Timeframe: 12 weeks

Trial details

NCT IDNCT04553666

SponsorUniversity of Rochester

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-31

Results submitted2024-08-07

View on ClinicalTrials.gov More Frailty trials

Who can participate

Age range65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

✕. 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.

What they're measuring

Recruitment Feasibility: Rates of Consent

Timeframe: Baseline

Recruitment Feasibility: Rates of Randomization

Timeframe: Baseline

The Proportion of Participants That Completed the Study

Timeframe: 12 week

The Proportion of Participants That Were Adherent to the Intervention

Timeframe: 12 week

Safety of the EGCG Intervention

Timeframe: 12 weeks