Reducing Frailty for Older Cancer Survivors Using Supplements

Inflammation Clinical Trial

— ReFOCUS  

Official title:

Reducing Frailty for Older Cancer Survivors Using Supplements (ReFOCUS): A Phase 2 Randomized Controlled Trial of Epigallocatechin-3-Gallate (EGCG) on Frailty and Inflammation in Older Survivors of Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04553666
• Other study ID #: UCCS20081
• Status: Completed
• Phase: Phase 2
• Start date: March 15, 2021
• Est. completion date: August 31, 2023

Study information

• Verified date: September 2023
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Frailty
• Inflammation

Intervention

Drug:
• Epigallocatechin-3-Gallate (EGCG) plus Ascorbic Acid (Vitamin C)
800mg Epigallocatechin-3-Gallate (EGCG) plus 250mg Ascorbic Acid (Vitamin C) taken one time a day for twelve weeks

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the recruitment feasibility of conducting a two arm randomized clinical trial of EGCG supplementation in older survivors of cancer	Recruitment feasibility will be measured by the rates of recruitment at the baseline time-point.	Baseline
Primary	To determine adherence of a two arm randomized clinical trial of EGCG supplementation in older survivors of cancer	The proportion of subjects that adhered to study procedures and the EGCG intervention at the 12 week time-point.	12 week