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NCT06113016 · ClinicalTrials.gov registry record · Phase 2
Prevention of Frailty With Fisetin and Exercise in 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
- 164
- Enrollment target
- 6
- Study locations
NCT06113016: 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.
NCT06113016 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 164 participants, below the 303-participant average among 84 other Anatomic Stage III Breast Cancer AJCC v8 trials with a reported enrollment target (46% lower). The trial reports 6 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06113016, 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
- 164 participants
- Enrollment target
- 6
- Study locations
Study Summary
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.
Primary Outcome
The 6MWD will assess the distance walked over 6 minutes and is measured in meters. A linear model will be fit to outcome variable (change score) with a factor variable representing the four study arms and control for baseline 6MWD, site, and age stratum. The analysis will be conducted as intention-to-treat analysis. Will conduct an as-treated analysis, comparing the treatments received (instead of as-randomized).
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- OTHER Exercise Intervention
- OTHER Educational Intervention
- DRUG Fisetin
- OTHER Physical Performance Testing
Study Locations (6)
California
- UCLA Health Cancer Care in Alhambra - Alhambra
- UCLA Health Beverly Hills Primary & Specialty Care - Beverly Hills
- UCLA Health Burbank Primary & Specialty Care - Burbank
- 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 | 164 participants |
| Start Date | 2024-07-23 |
| Est. Completion | 2028-12-30 |
| Phase | Phase 2 |
What NCT06113016 shows while recruiting
NCT06113016 is an interventional study that assigns participants to a tested intervention. The registered 164 participants enrollment target is mid-sized for trials with a published cap, below the 303-participant average among 84 other Anatomic Stage III Breast Cancer AJCC v8 trials with a reported enrollment target (46% lower).
The record links to 4 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.
NCT06113016 lists 6 locations in 1 state (California).
Frequently Asked Questions
What is clinical trial NCT06113016 about?
NCT06113016 is a clinical study titled "Prevention of Frailty With Fisetin and Exercise in Breast Cancer Survivors". 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 unde...
What is the current status of trial NCT06113016?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 164 participants. The study started on 2024-07-23. Estimated completion is 2028-12-30.
What conditions does trial NCT06113016 study?
This clinical trial studies the following conditions: Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Early Stage Breast Carcinoma, Anatomic Stage I Breast Cancer American Joint Committee on Cancer (AJCC) v8.
What interventions are being tested in trial NCT06113016?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Exercise Intervention (OTHER), Educational Intervention (OTHER), Fisetin (DRUG), Physical Performance Testing (OTHER).
Who is sponsoring clinical trial NCT06113016?
This trial is sponsored by Jonsson Comprehensive Cancer Center, which has 321 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06113016 being conducted?
This trial has 6 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 NCT06113016's enrollment target sits among peer trials
164 27th of 84 higher than 58 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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