Clinical trial · Interventional
Reducing Frailty for Older Cancer Survivors Using Supplements II
A Phase 2 Randomized Controlled Trial of Epigallocatechin-3-Gallate (EGCG) on Frailty and Inflammation in Older Survivors of Cancer
NCT06068543CI-TRIAL-00115990ReFOCUS2suspendedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study has been suspended by the IRB pending review of a study-related issue
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Frailty | — | UNRESOLVED | — |
| Inflammation | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ascorbic Acid (Vitamin C) | Dietary Supplement | — | UNRESOLVED |
| Epigallocatechin-3-Gallate (EGCG) | Drug | — | UNRESOLVED |
| Microcrystalline cellulose (MCC) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Epigallocatechin-3-Gallate (EGCG)
- description
- 800mg Epigallocatechin-3-Gallate (EGCG) pills AND 250mg Ascorbic Acid (Vitamin C) once daily
- interventionNames
- Drug: Epigallocatechin-3-Gallate (EGCG)
- Dietary Supplement: Ascorbic Acid (Vitamin C)
- type
- PLACEBO_COMPARATOR
- label
- Microcrystalline cellulose (MCC)
- description
- 800mg microcrystalline cellulose (MCC) pills AND 250mg Ascorbic Acid (Vitamin C) once daily
- interventionNames
- Drug: Microcrystalline cellulose (MCC)
- Dietary Supplement: Ascorbic Acid (Vitamin C)
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available
No reference posted for this study.