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NCT05595499 · ClinicalTrials.gov registry record · Phase 2
Fisetin to Improve Physical Function in Stage I-III Breast Cancer Survivors
A Phase 2 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, sponsored by Jonsson Comprehensive Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 88
- Enrollment target
- 7
- Study locations
NCT05595499: Recruiting Phase 2 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, sponsored by Jonsson Comprehensive Cancer Center.
NCT05595499 is a Phase 2 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8 that is actively recruiting participants, run by Jonsson Comprehensive Cancer Center. The registered enrollment target is 88 participants, below the 304-participant average among 84 other Anatomic Stage III Breast Cancer AJCC v8 trials with a reported enrollment target (71% lower). The trial reports 7 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05595499, a Phase 2 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, is actively recruiting participants, sponsored by Jonsson Comprehensive Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 88 participants
- Enrollment target
- 7
- Study locations
Study Summary
This phase II trial tests whether fisetin works to improve physical function in women who have received chemotherapy for stage I-III breast cancer treatment. Fisetin is a naturally occurring substance that is found in strawberries and other foods. Fisetin eliminates 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 causes inflammation and damages nearby healthy cells. Studies have shown that chemotherapy causes a build-up of these senescent cells. Giving fisetin may eliminate senescent cells and improve physical function in postmenopausal women who have received chemotherapy for breast cancer.
Primary Outcome
The 6MWD is a validated measure of physical function. Participants walk at their own pace for 6 minutes and distance (in meters) is measured at the end. Will be treated as a continuous variable. Its distribution will be transformed to normality as appropriate, Initially, a simple t-test will be used to compare the means of 6MWD at Day 60 by treatment groups.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- DRUG Fisetin
- DRUG Placebo Administration
Study Locations (7)
California
- UCLA Health Cancer Care in Alhambra - Alhambra
- UCLA Health Beverly Hills Primary & Specialty Care - Beverly Hills
- UCLA Health Burbank Primary & Specialty Care - Burbank
- City of Hope Comprehensive Cancer Center - Duarte
- UCLA / Jonsson Comprehensive Cancer Center - Los Angeles
- UCLA Health Primary Care in Marina del Rey - Marina del Rey
- UCLA Health Primary Care in Pasadena - Pasadena
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2023-03-27 |
| Est. Completion | 2026-06-01 |
| Phase | Phase 2 |
What NCT05595499 shows while recruiting
NCT05595499 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 304-participant average among 84 other Anatomic Stage III Breast Cancer AJCC v8 trials with a reported enrollment target (71% lower).
The record links to 3 conditions, with Anatomic Stage III Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05595499 lists 7 locations in 1 state (California).
Frequently Asked Questions
What is clinical trial NCT05595499 about?
NCT05595499 is a clinical study titled "Fisetin to Improve Physical Function in Stage I-III Breast Cancer Survivors". This phase II trial tests whether fisetin works to improve physical function in women who have received chemotherapy for stage I-III breast cancer treatment. Fisetin is a naturally occurring substance that is found in strawberries and other foods. Fisetin eliminates cells that have undergone a proce...
What is the current status of trial NCT05595499?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 88 participants. The study started on 2023-03-27. Estimated completion is 2026-06-01.
What conditions does trial NCT05595499 study?
This clinical trial studies the following conditions: Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8.
What interventions are being tested in trial NCT05595499?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Fisetin (DRUG), Placebo Administration (DRUG).
Who is sponsoring clinical trial NCT05595499?
This trial is sponsored by Jonsson Comprehensive Cancer Center, which has 321 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05595499 being conducted?
This trial has 7 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Anatomic Stage III Breast Cancer AJCC v8
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05595499's enrollment target sits among peer trials
88 37th of 84 higher than 48 of 84 other Anatomic Stage III Breast Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anatomic Stage III Breast Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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