Reducing Frailty for Older Cancer Survivors Using Supplements II

NCT ID: NCT06068543

Last Updated: 2025-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-30

Study Completion Date

2030-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Frailty Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients in the intervention Arm will receive 800 mg Epigallocatechin-3-Gallate (EGCG) + 250mg Ascorbic Acid
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Epigallocatechin-3-Gallate (EGCG)

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

Group Type EXPERIMENTAL

Epigallocatechin-3-Gallate (EGCG)

Intervention Type DRUG

800mg Epigallocatechin-3-Gallate (EGCG)

Ascorbic Acid (Vitamin C)

Intervention Type DIETARY_SUPPLEMENT

250mg Ascorbic Acid (Vitamin C) taken one time daily for 12 weeks

Microcrystalline cellulose (MCC)

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

Group Type PLACEBO_COMPARATOR

Microcrystalline cellulose (MCC)

Intervention Type DRUG

800mg microcrystalline cellulose (MCC)

Ascorbic Acid (Vitamin C)

Intervention Type DIETARY_SUPPLEMENT

250mg Ascorbic Acid (Vitamin C) taken one time daily for 12 weeks

Interventions

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Epigallocatechin-3-Gallate (EGCG)

800mg Epigallocatechin-3-Gallate (EGCG)

Intervention Type DRUG

Microcrystalline cellulose (MCC)

800mg microcrystalline cellulose (MCC)

Intervention Type DRUG

Ascorbic Acid (Vitamin C)

250mg Ascorbic Acid (Vitamin C) taken one time daily for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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EGCG MCC Vitamin C

Eligibility Criteria

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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).
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Nikesha Gilmore

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Rochester

Rochester, New York, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Nikesha Gilmore, PhD

Role: primary

5852751275

Other Identifiers

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UOCPC23048

Identifier Type: -

Identifier Source: org_study_id

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