FrailtyPhase 2ReFOCUS1NCT04553666
Reducing Frailty for Older Cancer Survivors Using Supplements
A Phase 2 study testing Epigallocatechin-3-Gallate (EGCG) plus Ascorbic Acid (Vitamin C) in people with Frailty and Inflammation, run by University of Rochester at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty, Inflammation
- What is being tested?
- Epigallocatechin-3-Gallate (EGCG) plus Ascorbic Acid (Vitamin C)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2021to 31 Aug 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Being tested
- Epigallocatechin-3-Gallate (EGCG) plus Ascorbic Acid (Vitamin C)
- Medical subject headings
- Frailty, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epigallocatechin-3-Gallate (EGCG) plus Ascorbic Acid (Vitamin C)Drug
Also called EGCG plus Vitamin C
800mg Epigallocatechin-3-Gallate (EGCG) plus 250mg Ascorbic Acid (Vitamin C) taken one time a day for twelve weeks
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Four 200mg EGCG pills and one 250mg Vitamin C pill taken one time each day Receives: Drug: Epigallocatechin-3-Gallate (EGCG) plus Ascorbic Acid (Vitamin C) |
| Usual Care Group | No intervention | No study pills |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Feasibility: Rates of Consent
Recruitment feasibility will be determined by the proportion of participants approached compared to those consented onto the study.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start28 Apr 2021
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients in the intervention Arm will receive 800 mg Epigallocatechin gallate (EGCG) + 250mg Ascorbic Acid
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nikesha Gilmore, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04553666
- Sponsor's protocol ID
- UCCS20081
- Acronym
- ReFOCUS1
- Status last verified
- Apr 2026
- First submitted
- 4 Sep 2020
- Last updated
- 7 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04553666
- Acronym / sponsor ID
- ReFOCUS1 / UCCS20081
- Conditions
- Frailty, Inflammation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 28 Apr 2021 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 17 Sep 2020 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients in the intervention Arm will receive 800 mg Epigallocatechin gallate (EGCG) + 250mg Ascorbic Acid
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Drug: Epigallocatechin-3-Gallate (EGCG) plus Ascorbic Acid (Vitamin C)Four 200mg EGCG pills and one 250mg Vitamin C pill taken one time each day |
| Usual Care Group | No intervention | –No study pills |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epigallocatechin-3-Gallate (EGCG) plus Ascorbic Acid (Vitamin C)Also: EGCG plus Vitamin C800mg Epigallocatechin-3-Gallate (EGCG) plus 250mg Ascorbic Acid (Vitamin C) taken one time a day for twelve weeks | Drug | Intervention Group |
Primary outcome
Recruitment Feasibility: Rates of Consent
Time frame: Baseline
Recruitment feasibility will be determined by the proportion of participants approached compared to those consented onto the study.
Recruitment Feasibility: Rates of Randomization
Time frame: Baseline
Recruitment feasibility will be determined by the proportion of participants consented compared to those randomized into one of the study arms.
The Proportion of Participants That Completed the Study
Time frame: 12 week
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.
The Proportion of Participants That Were Adherent to the Intervention
Time frame: 12 week
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).
Safety of the EGCG Intervention
Time frame: 12 weeks
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Epigallocatechin-3-Gallate (EGCG) plus Ascorbic Acid (Vitamin C) in people with Frailty and Inflammation, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Feasibility: Rates of Consent (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.