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Prevention of Frailty With Fisetin and Exercise in Breast Cancer Survivors

Study acronym: PROFFi
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 months later Jun 30, 2028 → Oct 31, 2028
See other at-risk trials from Jonsson Comprehensive Cancer Center

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Jun 30, 2028 to Oct 31, 2028
    • Study completion pushed from Dec 30, 2028 to Oct 31, 2031
    • Site contacts updated at 1 of 6 sites
    v14
  2. Site contacts updated at 1 of 6 sitesv13
  3. Start date: Apr 17, 2024 to Jul 23, 2024
    • Primary completion date: Oct 31, 2028 to Jun 30, 2028
    • Study completion date: Oct 31, 2031 to Dec 30, 2028
    v12
  4. Primary completion date: Aug 31, 2028 to Oct 31, 2028v11 Show 5 more changesShow less
    • Study completion date: Aug 31, 2031 to Oct 31, 2031
    • Eligibility criteria expanded, about 18 words
    • Site contacts updated at 1 of 6 sites
    • Collaborators: 2 to 3
    • Study title shortened, about 1 word
  5. Study sites: 1 to 6v10
Show 8 earlier versionsHide 8 earlier versions
  1. Start date changed from estimate of Jul 30, 2024 to Apr 17, 2024v9
  2. Start date: Jul 2024 to Jul 30, 2024v8
  3. Primary completion date: Oct 31, 2026 to Aug 31, 2028
    • Start date: Apr 17, 2024 to Jul 2024
    • Study completion date: Oct 31, 2027 to Aug 31, 2031
    v7
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 30, 2024 to Apr 17, 2024
    • Site details revised
    v6
  5. Start date: Dec 31, 2023 to Sep 30, 2024v5
  6. Study title expanded, about 2 wordsv4
  7. Start date: Oct 31, 2023 to Dec 31, 2023v3
  8. Secondary endpoints: details revised at 3 of 15 entriesv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This phase II trial tests how well fisetin and exercise works in preventing frailty in breast cancer survivors. Fisetin is a natural substance found in strawberries and other foods and is available as a nutritional supplement. Nutritional supplements may be useful in eliminating cells that have undergone a process called senescence. Senescence is when a cell ages and permanently stops dividing but does not die. Over time, large numbers of these cells build up in tissues throughout the body and can release harmful substances that cause inflammation and damage nearby healthy cells. Giving fisetin may eliminate senescent cells in patients with breast cancer undergoing physical activity.
Trial Details
NCT Number NCT06113016
Lead Sponsor Jonsson Comprehensive Cancer Center
Collaborators: National Institutes of Health (NIH), National Cancer Institute (NCI), Rising Tide Foundation
Conditions
(from sponsor)		 Anatomic Stage I Breast Cancer American Joint Committee on Cancer (AJCC) v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Early Stage Breast Carcinoma
Enrollment 164 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov