Reducing Frailty for Older Cancer Survivors Using Supplements II (ReFOCUS2)

University of Rochester

Status and phase: Enrolling; Phase 2

Conditions: Inflammation; Frailty

Treatments: Drug: Microcrystalline cellulose (MCC); Drug: Epigallocatechin-3-Gallate (EGCG); Dietary Supplement: Ascorbic Acid (Vitamin C)

Study type: Interventional

Funder types: Other

Identifiers

NCT06068543

UOCPC23048

Details and patient eligibility

About

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.

Enrollment: 118 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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 the following endocrine therapies are allowed to enroll (Anastrozole,Leuprolide acetate, and Bicalutamide)
4. Have a Fried's Frailty Score (FFS) of ≥ 1
5. Able to provide informed consent

Exclusion criteria

1. Have chemotherapy or other systemic cancer treatment planned to occur during the study period.

2. Have abnormal liver function tests (ALT, AST, and bilirubin) per most recent available lab test (within 3 months of screening)

   • 3 times institutional upper limit of normal for ALT and AST
   • 1.5 times institutional upper limit of normal for bilirubin

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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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118 participants in 2 patient groups, including a placebo group

Epigallocatechin-3-Gallate (EGCG)

Experimental group

Description:

800mg Epigallocatechin-3-Gallate (EGCG) pills AND 250mg Ascorbic Acid (Vitamin C) once daily

Treatment:

Dietary Supplement: Ascorbic Acid (Vitamin C)

Drug: Epigallocatechin-3-Gallate (EGCG)

Microcrystalline cellulose (MCC)

Placebo Comparator group

Description:

800mg microcrystalline cellulose (MCC) pills AND 250mg Ascorbic Acid (Vitamin C) once daily

Treatment:

Dietary Supplement: Ascorbic Acid (Vitamin C)

Drug: Microcrystalline cellulose (MCC)