Tier 4 — mechanistic

Prevention of Frailty With Fisetin and Exercise in Breast Cancer Survivors (PROFFi)

PROFFi Trial
Not applicable - trial registered on ClinicalTrials.gov (not yet published in a peer-reviewed journal) 2023 Not applicable (trial registry record, no journal volume/issue/pages)

Bibliography

Trial registry
View on ClinicalTrials.gov Registered trial — results not yet published in a peer-reviewed journal.
Funding
Sponsor: Jonsson Comprehensive Cancer Center (UCLA). Collaborators: National Institutes of Health (NIH), National Cancer Institute (NCI), Rising Tide Foundation. Other IDs: 23-001171; P30CA016042; R01CA280088; NCI-2023-06774.
Competing interests
Not disclosed in the ClinicalTrials.gov registry record; NIH/NCI and Rising Tide Foundation are listed funding collaborators.

Study snapshot

DesignRandomised, parallel-group, triple-blind (participant, investigator, outcomes assessor), placebo-controlled Phase 2 interventional trial with a 2x2 factorial design (fisetin and/or exercise intervention).
ModelHuman participants: female breast cancer survivors (Anatomic Stage I-III breast cancer, AJCC v8).
SamplePlanned enrollment: 164 participants.
InterventionOral fisetin (drug) and/or a structured exercise intervention, compared against placebo administration, alongside educational intervention, biospecimen collection and physical performance/quality-of-life testing across four study arms (fisetin, exercise, fisetin+exercise, control).
DurationFisetin/placebo is administered on days 1–3 of each 14-day cycle for 8 cycles (16 weeks); supervised exercise is delivered over 16 weeks where assigned. Primary physical-function assessment is from baseline to day 120, with longer-term follow-up extending annually for up to 3 years.
EndpointsChange in 6-minute walk distance (6MWD); Change in short physical performance battery (SPPB), grip strength and frailty phenotype; Chemotherapy-induced peripheral neuropathy and cognitive function (PROMIS) scores; Quality of life (SF-36); Local/distant recurrence-free survival, breast-cancer-specific survival and overall survival; Incidence of adverse events (NCI CTCAE v5.0) and treatment adherence

What the study showed, in plain terms

PROFFi (NCT06113016) is an ongoing randomized Phase 2 trial in breast-cancer survivors testing fisetin, supervised exercise, their combination and control conditions. The study focuses on physical function, frailty and survivorship outcomes after cancer treatment.

No trial results are available. Because exercise is a co-intervention in the factorial design, future results will need arm-specific analysis to separate the effect of fisetin from exercise and any interaction between them.

Key findings

  • No efficacy or safety outcome results are posted.
  • The planned study includes 164 breast-cancer survivors in a factorial design testing fisetin and exercise.
  • Physical function and frailty are central outcomes, with longer-term survivorship measures also tracked.

What this study can and cannot tell us

  • Ongoing trial with no results.
  • Factorial co-intervention design requires arm-specific interpretation; a combined-group effect should not be attributed automatically to fisetin.
  • Cancer-survivor findings may not generalize to healthy adults using fisetin for longevity.

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Dr. Khaled Mahmoud, MBBChCritical Care Medicine, Longevity Science & Editorial Direction Dr. Abdulla Mostafa, PhDCellular Senescence, Neurological, Mitochondrial & Brain-Ageing Biology Dr. Amr Yasser, PhDCardiometabolic, Musculoskeletal, Gut & Bioavailability