Tier 2 — strong

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

DOI: NOT AVAILABLE - unpublished trial registration, no DOI assigned
PubMed: PMID NOT AVAILABLE - unpublished trial registration, no PMID assigned
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

Design	Randomised, parallel-group, triple-blind (participant, investigator, outcomes assessor), placebo-controlled Phase 2 interventional trial with a 2x2 factorial design (fisetin and/or exercise intervention).
Model	Human participants: female breast cancer survivors (Anatomic Stage I-III breast cancer, AJCC v8).
Sample	Planned enrollment: 164 participants.
Intervention	Oral 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).
Duration	Primary outcome assessed from baseline to day 120; secondary survival outcomes followed up to 3 years; estimated study start 2024-07-23, primary completion 2028-06-30, full completion 2028-12-30 (registry data).
Endpoints	Change 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

This is not yet a published research paper - it is a clinical trial currently recruiting (registered on ClinicalTrials.gov as NCT06113016), sponsored by the UCLA Jonsson Comprehensive Cancer Center with funding from the US National Cancer Institute and the Rising Tide Foundation.

The trial is testing whether fisetin, exercise, or the combination of both can help prevent frailty in women who have survived early-to-locally-advanced breast cancer (Stages I-III) - a population known to be at higher risk of accelerated ageing and physical decline after cancer treatment.

Participants are randomised into one of four groups (fisetin, exercise, fisetin plus exercise, or placebo/control) and followed for physical function (walking distance, grip strength, frailty scoring), quality of life, chemotherapy-related nerve symptoms, and long-term cancer outcomes over several years.

As with the Fisetin HIGH trial in this Data Center, no results exist yet from PROFFi - it is included here as a trial-in-progress so this Data Center reflects the current pipeline of human fisetin research relevant to cancer survivorship and senescence-related frailty.

A specific identifier gap for this entry: the ClinicalTrials.gov record reviewed lists the sponsoring institution but no named principal investigator, so the handle and authors field use the trial's sponsor and acronym rather than a person's name; this should be corrected once a named investigator or publication is available.

Key findings

No results are available yet - this trial is registered as RECRUITING and has not been completed or published
Planned design: randomised, triple-blind, placebo-controlled Phase 2 trial in 164 breast cancer survivors, testing fisetin and/or exercise
Planned outcomes include physical function, frailty phenotype, quality of life, and long-term survival measures
This entry will need updating with a PMID and DOI once results are published in a peer-reviewed journal

What this study can and cannot tell us

This is a trial registration record, not a peer-reviewed publication - no results, statistical analysis, or conclusions currently exist for this study.

No named principal investigator was available in the registry fields reviewed for this record; the handle and author field flag this gap rather than fabricating a name.

Estimated study dates (start 2024, completion 2028, per the registry) mean published results are not expected for some time; this Data Center entry should be revisited and upgraded once a results publication with a PMID/DOI becomes available.