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Fisetin for Breast Cancer Survivors

Phase 2

Recruiting

Led By Mina Sedrak, MD

Research Sponsored by Jonsson Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have completed chemotherapy within 12 months.

Age: >= 65 years at the time of cancer diagnosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial tests whether fisetin from strawberries can reduce senescent cells and improve physical function in breast cancer patients.

Who is the study for?

This trial is for postmenopausal women aged 65 or older who have had stage I-III breast cancer treated with chemotherapy within the last year. Participants must be able to walk on their own, even if they use a cane or walker, but have a reduced walking ability (less than 400m in 6 minutes). They should not have had surgery or radiation in the past month and must agree to stop certain natural medications before and during the study.Check my eligibility

What is being tested?

The TROFFi trial is testing fisetin, a substance found in strawberries that might remove aging cells built up from chemotherapy, which could improve physical function. Women will either receive fisetin or a placebo while also undergoing quality-of-life assessments through questionnaires and biospecimen collection.See study design

What are the potential side effects?

While specific side effects of fisetin are not detailed here, potential risks may include reactions similar to other oral medications such as digestive discomfort. Since it's being tested for its effects on aging cells after chemotherapy, monitoring for any unusual symptoms will be important.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I finished my chemotherapy less than a year ago.

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I was 65 or older when my cancer was diagnosed.

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I had breast cancer (stage I-III) treated with chemo before or after surgery.

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I was postmenopausal when my cancer was diagnosed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in 6-minute walk distance (6MWD)

Secondary outcome measures

Adherence rate

Adverse events rates

Breast cancer specific survival and overall survival

+14 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm A (fisetin)Experimental Treatment4 Interventions

Patients receive fisetin PO on days 1, 2, and 3. Treatment repeats every 2 weeks for up to 8 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples throughout the trial.

Group II: Arm B (placebo)Placebo Group4 Interventions

Patients receive placebo PO on the trial. on days 1, 2, and 3. Treatment repeats every 2 weeks for up to 8 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 2

~1700

Fisetin

2016

Completed Phase 2

~170

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH

1,675 Previous Clinical Trials

28,020,837 Total Patients Enrolled

14 Trials studying Breast Cancer

40,449 Patients Enrolled for Breast Cancer

Jonsson Comprehensive Cancer CenterLead Sponsor

360 Previous Clinical Trials

27,624 Total Patients Enrolled

24 Trials studying Breast Cancer

1,758 Patients Enrolled for Breast Cancer

City of Hope Medical CenterLead Sponsor

567 Previous Clinical Trials

1,922,572 Total Patients Enrolled

43 Trials studying Breast Cancer

6,649 Patients Enrolled for Breast Cancer

Media Library

Fisetin (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05595499 — Phase 2

Breast Cancer Research Study Groups: Arm A (fisetin), Arm B (placebo)

Breast Cancer Clinical Trial 2023: Fisetin Highlights & Side Effects. Trial Name: NCT05595499 — Phase 2

Fisetin (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05595499 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any dangers that have been associated with Arm A (fisetin)?

"Arm A (fisetin) is currently in Phase 2 of clinical trials. While there is evidence suggesting that it is safe, more research needs to be done to determine if it is an effective treatment."

Answered by AI

Are there any more spots available for this research program?

"No, this particular clinical trial is not presently recruiting patients for participation. The study was first posted on November 5th, 2022 and was last updated a few days ago on the 2nd of November. Although this specific trial isn't searching for volunteers at the moment, there are 2372 other trials that are currently enrolling patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Fisetin to Improve Physical Function in Stage I-III Breast Cancer Survivors

2023. "Fisetin to Improve Physical Function in Stage I-III Breast Cancer Survivors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05595499.