Reducing Frailty for Older Cancer Survivors Using Supplements

NCT ID: NCT04553666

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-28
• Study Completion Date: 2023-08-31

Brief 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

Conditions

Frailty; Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention Group

Four 200mg EGCG pills and one 250mg Vitamin C pill taken one time each day

Group Type: EXPERIMENTAL

Epigallocatechin-3-Gallate (EGCG) plus Ascorbic Acid (Vitamin C)

Intervention Type: DRUG

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

Usual Care Group

No study pills

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DRUG

Other Intervention Names

EGCG plus Vitamin C

Eligibility Criteria

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

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Nikesha Gilmore

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Rochester

Rochester, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

UCCS20081

Identifier Type: -

Identifier Source: org_study_id