Reducing Frailty for Older Cancer Survivors Using Supplements

NCT04553666 | Completed Phase 2 Results FDA Drug

• 1 other identifier: UCCS20081
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• Recruitment Feasibility: Rates of Consent

  Recruitment feasibility will be determined by the proportion of participants approached compared to those consented onto the study.

  Baseline

• Recruitment Feasibility: Rates of Randomization

  Recruitment feasibility will be determined by the proportion of participants consented compared to those randomized into one of the study arms.

  Baseline

• The Proportion of Participants That Completed the Study

  To determine adherence of a two arm randomized clinical trial of EGCG supplementation in older survivors of cancer by determining how many participants completed the study.The number of participants randomized compared to the number of participants that returned for the post intervention visit.

  12 week

• The Proportion of Participants That Were Adherent to the Intervention

  To determine adherence of a two arm randomized clinical trial of EGCG supplementation in older survivors of cancer by determining the proportion of participants that were adherent to the intervention (taking \>70% of study drug).

  12 week

• Safety of the EGCG Intervention

  Total (sum) and severity of adverse events (AEs) reported over 12 weeks of being on study graded using CTCAE v5.0 was determined. Participants were called weekly by study coordinator and asked to report concerns including: symptoms, signs, illnesses, or experiences that develop or worsen during the study. These concerns were graded according to the CTCAE v5.0. Number of participants who reported any AEs during the 12 weeks of the study are reported.

  12 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

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

Usual Care Group

NO INTERVENTION

No study pills

Interventions

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

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

Also known as: EGCG plus Vitamin C

Intervention Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Be age 65 or over.
• Be diagnosed with stage I-III Cancer.
• Have completed curative intent treatment ≤10 years prior to screening. (Patients on endocrine therapies are allowed to enroll.)
• Have a Fried's Frailty Score (FFS) of ≥ 2.
• 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.

You may not qualify if:

• Have chemotherapy planned for the during of the study.
• 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).
• Have uncontrolled or unmanaged liver disease.
• Consume more than 6 cups of green tea per day.
• Have known allergies to caffeine.
• Be diagnosed with a major psychiatric illness requiring hospitalization within the last year.
• Be diagnosed with dementia.
• 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.

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester

Rochester, New York, 14627, United States

Location

MeSH Terms

Conditions

Frailty; Inflammation

Interventions

epigallocatechin gallate; Ascorbic Acid

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Results Point of Contact

• Title: Dr. Nikesha Gilmore, Assistant Professor
• Organization: University of Rochester Medical Center

nikesha_gilmore@urmc.rochester.edu

1-585-275-1275

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Patients in the intervention Arm will receive 800 mg Epigallocatechin gallate (EGCG) + 250mg Ascorbic Acid

Study Record Dates

• First Submitted: September 4, 2020
• First Posted: September 17, 2020
• Study Start: April 28, 2021
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Locations

US (1)