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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

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in 6-minute walk distance (6MWD)

Secondary study objectives

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 3

~2020

Fisetin

2016

Completed Phase 2

~250