RECRUITING

Reducing Frailty for Older Cancer Survivors Using Supplements II

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 2 Randomized Controlled Trial of Epigallocatechin-3-Gallate (EGCG) on Frailty and Inflammation in Older Survivors of Cancer

Quick Facts

Study Start:2024-06-28

Study Completion:2030-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06068543

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Locations (Sites)

University of Rochester

Rochester, New York, 14627

United States

Collaborators and Investigators

Sponsor: University of Rochester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-28

Study Completion Date2030-12-31

Study Record Updates

Study Start Date2024-06-28

Study Completion Date2030-12-31

Terms related to this study

Additional Relevant MeSH Terms

Frailty
Inflammation