Reducing Frailty for Older Cancer Survivors Using Supplements II

Inflammation Clinical Trial

— ReFOCUS2  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06068543
• Other study ID #: UOCPC23048
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 1, 2024
• Est. completion date: December 31, 2030

Study information

• Verified date: April 2024
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 118
• Est. completion date: December 31, 2030
• Est. primary completion date: January 1, 2030
• 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 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.

Related Conditions & MeSH terms

• Frailty
• Inflammation

Intervention

Drug:
• Epigallocatechin-3-Gallate (EGCG)
800mg Epigallocatechin-3-Gallate (EGCG)
• Microcrystalline cellulose (MCC)
800mg microcrystalline cellulose (MCC)

Dietary Supplement:
• Ascorbic Acid (Vitamin C)
250mg Ascorbic Acid (Vitamin C) taken one time daily for 12 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	Change of physical frailty measured using the Short Physical Performance Battery (SPPB) in patients in the EGCG arm compared to placebo; change in SPPB scores from baseline to 12 weeks.	We will assess the change in SPPB scores from baseline to 12 weeks after baseline in patients in the EGCG intervention arm compared to the placebo arm.	12 Weeks