Reducing Frailty for Older Cancer Survivors Using Supplements II

Part of paid clinical trials in Rochester, New York.

Sponsor
University of Rochester
Study ID
NCT06068543
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Frailty
  • Inflammation

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Epigallocatechin-3-Gallate (EGCG) — DRUG
    800mg Epigallocatechin-3-Gallate (EGCG)
  • Microcrystalline cellulose (MCC) — DRUG
    800mg microcrystalline cellulose (MCC)
  • Ascorbic Acid (Vitamin C) — DIETARY_SUPPLEMENT
    250mg Ascorbic Acid (Vitamin C) taken one time daily for 12 weeks

Study Details

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.

Key Dates

Start date
Oct 25, 2024
Status verified
Mar 2026
Primary completion
Jan 1, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
118 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Epigallocatechin-3-Gallate (EGCG)
    800mg Epigallocatechin-3-Gallate (EGCG) pills AND 250mg Ascorbic Acid (Vitamin C) once daily
  • Placebo Comparator: Microcrystalline cellulose (MCC)
    800mg microcrystalline cellulose (MCC) pills AND 250mg Ascorbic Acid (Vitamin C) once daily

Primary Outcome Measure

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. [ Time Frame: 12 Weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of RochesterRochesterNew York14627
Nikesha Gilmore, PhD
[email protected]
5852751275

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By research site
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