Clinical trial · Interventional
Reducing Frailty for Older Cancer Survivors Using Supplements
Reducing Frailty for Older Cancer Survivors Using Supplements (ReFOCUS): A Pilot Randomized Controlled Trial of the Feasibility, Safety, and Preliminary Effects of Epigallocatechin-3-Gallate (EGCG) in Pre-Frail and Frail Older Cancer Survivors
NCT04553666CI-TRIAL-00110749ReFOCUS1completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Epigallocatechin-3-Gallate (EGCG) plus Ascorbic Acid (Vitamin C) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention Group
- description
- Four 200mg EGCG pills and one 250mg Vitamin C pill taken one time each day
- interventionNames
- Drug: Epigallocatechin-3-Gallate (EGCG) plus Ascorbic Acid (Vitamin C)
- type
- NO_INTERVENTION
- label
- Usual Care Group
- description
- No study pills
Primary outcomes (5)
- measure
- Recruitment Feasibility: Rates of Consent
- timeFrame
- Baseline
- description
- Recruitment feasibility will be determined by the proportion of participants approached compared to those consented onto the study.
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 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: Study subjects must not: 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.
References
Publications (0)
Data not yet available
No reference posted for this study.