FrailtyPhase 2ReFOCUS2NCT06068543
Reducing Frailty for Older Cancer Survivors Using Supplements II
A Phase 2 study testing Epigallocatechin-3-Gallate (EGCG), Microcrystalline cellulose (MCC) and Ascorbic Acid (Vitamin C) in people with Frailty and Inflammation, run by University of Rochester at 1 site in United States.
Trial summary
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. 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), Microcrystalline cellulose (MCC) and Ascorbic Acid (Vitamin C)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2024to 31 Dec 2030
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 the following endocrine therapies are allowed to enroll (Anastrozole,Leuprolide acetate, and Bicalutamide)
- Have a Fried's Frailty Score (FFS) of ≥ 1
- Able to provide informed consent
Who cannot join
- Have chemotherapy or other systemic cancer treatment planned to occur during the study period.
- 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
- Have uncontrolled or unmanaged liver disease.
- Consume more than 6 cups of green tea per day.
Show all 10Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2 Randomized Controlled Trial of Epigallocatechin-3-Gallate (EGCG) on Frailty and Inflammation in Older Survivors of Cancer
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
- Frailty, Inflammation
- Being tested
- Epigallocatechin-3-Gallate (EGCG), Microcrystalline cellulose (MCC), 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)Drug
Also called EGCG
800mg Epigallocatechin-3-Gallate (EGCG)
Microcrystalline cellulose (MCC)Drug
Also called MCC
800mg microcrystalline cellulose (MCC)
Ascorbic Acid (Vitamin C)Dietary supplement
Also called Vitamin C
250mg Ascorbic Acid (Vitamin C) taken one time daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Epigallocatechin-3-Gallate (EGCG) | Experimental | 800mg Epigallocatechin-3-Gallate (EGCG) pills AND 250mg Ascorbic Acid (Vitamin C) once daily Receives: Drug: Epigallocatechin-3-Gallate (EGCG); Dietary Supplement: Ascorbic Acid (Vitamin C) |
| Microcrystalline cellulose (MCC) | Placebo comparator | 800mg microcrystalline cellulose (MCC) pills AND 250mg Ascorbic Acid (Vitamin C) once daily Receives: Drug: Microcrystalline cellulose (MCC); Dietary Supplement: Ascorbic Acid (Vitamin C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
We will assess the change in SPPB scores from baseline to 12 weeks after baseline in patients in the EGCG intervention arm compared to the placebo arm.
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 posted5 Oct 2023
- Study start25 Oct 2024
- Primary completion1 Jan 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Why it stopped: The study has been suspended by the IRB pending review of a study-related issue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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-3-Gallate (EGCG) + 250mg Ascorbic Acid
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 118 participants (estimated)
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
- NCT06068543
- Sponsor's protocol ID
- UOCPC23048
- Acronym
- ReFOCUS2
- Status last verified
- Mar 2026
- First submitted
- 20 Sep 2023
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized Controlled Trial of Epigallocatechin-3-Gallate (EGCG) on Frailty and Inflammation in Older Survivors of Cancer
- ClinicalTrials.gov ID
- NCT06068543
- Acronym / sponsor ID
- ReFOCUS2 / UOCPC23048
- Conditions
- Frailty, Inflammation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The study has been suspended by the IRB pending review of a study-related issue
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 25 Oct 2024 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 5 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Patients in the intervention Arm will receive 800 mg Epigallocatechin-3-Gallate (EGCG) + 250mg Ascorbic Acid
| Arm | Type | Receives |
|---|---|---|
| Epigallocatechin-3-Gallate (EGCG) | Experimental | Drug: Epigallocatechin-3-Gallate (EGCG), Dietary Supplement: Ascorbic Acid (Vitamin C)800mg Epigallocatechin-3-Gallate (EGCG) pills AND 250mg Ascorbic Acid (Vitamin C) once daily |
| Microcrystalline cellulose (MCC) | Placebo comparator | Drug: Microcrystalline cellulose (MCC), Dietary Supplement: Ascorbic Acid (Vitamin C)800mg microcrystalline cellulose (MCC) pills AND 250mg Ascorbic Acid (Vitamin C) once daily |
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 the following endocrine therapies are allowed to enroll (Anastrozole,Leuprolide acetate, and Bicalutamide)
- Have a Fried's Frailty Score (FFS) of ≥ 1
- Able to provide informed consent
Key exclusion criteria (10 listed)
- Have chemotherapy or other systemic cancer treatment planned to occur during the study period.
- Have abnormal liver function tests (ALT, AST, and bilirubin) 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)Also: EGCG800mg Epigallocatechin-3-Gallate (EGCG) | Drug | Epigallocatechin-3-Gallate (EGCG) |
| Microcrystalline cellulose (MCC)Also: MCC800mg microcrystalline cellulose (MCC) | Drug | Microcrystalline cellulose (MCC) |
| Ascorbic Acid (Vitamin C)Also: Vitamin C250mg Ascorbic Acid (Vitamin C) taken one time daily for 12 weeks | Dietary supplement | Epigallocatechin-3-Gallate (EGCG), Microcrystalline cellulose (MCC) |
Primary outcome
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
We will assess the change in SPPB scores from baseline to 12 weeks after baseline in patients in the EGCG intervention arm compared to the placebo arm.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
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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), Microcrystalline cellulose (MCC) and 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 10 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: paused, as of the sponsor's last update on 26 Jun 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
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). 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 26 Jun 2026.