# PROFFi: fisetin and exercise to prevent frailty in breast cancer survivors

Source: https://onco.cc/trials/rejuv-trial-proffi/  
OnCo record `rejuv-trial-proffi` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The first randomised trial to test a senolytic in people who have had cancer. Four arms crossing fisetin against placebo with tailored supervised exercise against a physical activity handout, and the primary endpoint is how far someone can walk in six minutes.

## Summary

Fisetin is a flavonol found in strawberries and sold as a supplement, and it is being tested here as a senolytic, a drug meant to clear senescent cells. The frontier record on senolytics in this corpus states the gap this trial addresses: fisetin is in trials but has no completed randomised result in cancer survivors, and the human evidence for senolytics generally is four small trials in other diseases with the one properly randomised trial missing its primary endpoint.

The design is a two-by-two: fisetin or placebo by mouth on days 1 to 3 of each 14-day cycle for eight cycles, crossed with either individually tailored supervised exercise training (30 to 45 minutes of aerobic and 20 to 30 minutes of resistance work) or a handout on the importance of physical activity. The registry describes it as triple-masked with respect to the study agent, with the outcomes assessor blinded to training status because participants cannot be blinded to exercise. The primary endpoint is change in six-minute walk distance from baseline to day 120.

The reason this trial matters beyond its drug is the endpoint. It measures something a person would notice rather than a marker, in a population where the marker has been shown to move, which is exactly the design the biological-ageing agenda record argues the field needs. Whether fisetin works is a smaller question than whether a trial of this shape can be run at all.

Registry dates, read on 2 October 2026: start 23 July 2024 (actual), primary completion 31 October 2028 (estimated), completion 31 October 2031 (estimated). Enrolment of 164 is the registry's estimate, not an achieved figure.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-10-02
- Also known as: PROFFi; NCT06113016
- Tags: rejuvenation; survivorship; open-problem; biological-ageing; senolytics; exercise
- Registry id: NCT06113016
- Phase: 2
- Setting: Breast cancer survivors after treatment for anatomic stage I to III breast cancer, United States
- Sponsor: Jonsson Comprehensive Cancer Center, with the National Cancer Institute and the Rising Tide Foundation
- Enrolled: 164

## Sources

- ClinicalTrials.gov NCT06113016: https://clinicaltrials.gov/study/NCT06113016

## Connected records

- technologies: [Frailty and late effects in survivors](https://onco.cc/technologies/rejuv-age-frailty-and-late-effects/), [Senescent cells and p16 after chemotherapy](https://onco.cc/technologies/rejuv-age-senescent-cells-after-treatment/), [Senolytics after cancer treatment](https://onco.cc/technologies/rejuv-frontier-senolytics/), [The exercise prescription after cancer: the dose the guidelines state](https://onco.cc/technologies/exercise-prescription-after-cancer/)
- bottlenecks: [Nobody has tested whether reversing measured biological ageing changes anything](https://onco.cc/bottlenecks/rejuv-agenda-biological-age-as-an-untested-target/)
- ideas: [Put a biological-age marker in a trial that also measures something a person would notice](https://onco.cc/ideas/idea-rejuv-biological-age-as-a-randomised-endpoint/)
- roadmaps: [Recovery and rejuvenation roadmap: cure is not enough → survivorship gets a name → the cohorts that measured the cost → exercise proven as treatment → biological ageing measured and sold → repair, if anyone funds it](https://onco.cc/roadmaps/rejuvenation-roadmap/)
- cancers: [Breast cancer (all types)](https://onco.cc/cancers/breast-cancer/)
- fronts: [Recovery & Rejuvenation](https://onco.cc/fronts/rejuvenation/), [Supportive Care & Survivorship](https://onco.cc/fronts/supportive-care/)

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