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NCT05327608 · ClinicalTrials.gov registry record · NA
Neoadjuvant Breast Cancer Time Restricted Eating
A NA study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, sponsored by Thomas Jefferson University.
- Recruiting
- Registry status
- NA
- Development phase
- 55
- Enrollment target
- 1
- Study location
NCT05327608: Recruiting NA study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, sponsored by Thomas Jefferson University.
NCT05327608 is a NA study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8 that is actively recruiting participants, run by Thomas Jefferson University. The registered enrollment target is 55 participants, below the 304-participant average among 84 other Anatomic Stage III Breast Cancer AJCC v8 trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05327608, a NA study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, is actively recruiting participants, sponsored by Thomas Jefferson University.
- RECRUITING
- Registry status
- NA
- Development phase
- 55 participants
- Enrollment target
- 1
- Study location
Study Summary
A phase II study to evaluate an innovative approach of following time restricted eating (TRE) in patients with HER2- negative breast cancer who will start neoadjuvant chemotherapy (NCT) for a new diagnosis of stage I-III breast cancer. Participants at baseline will have a body mass index (BMI) of (25-40) and engage in a TRE 16:8 schedule which includes 16 hours of fasting and 8 hours of eating. Patients will continue TRE for 16 weeks while receiving NCT. For patients who report at the time of the 2-3 week clinic visit that they are finding it challenging to adhere to the 16:8 TRE, instructions will be provided about alternative measures such as changing the time of the day they fast, dietary modifications and finally changing to a 14:10 schedule if other measures fail. For patients requiring NCT for longer than 16 weeks, they will be encouraged to continue TRE. Adherence calculation for the primary endpoint will include data for the first 16 weeks, and then monitored separately for any additional optional fasting beyond the first 16 weeks. Adherence to TRE will be self-reported by patients daily through electronic surveys through RedCap and approximately every 2-3 weeks (+/- 5 days) by the research team during their clinic visit.
Primary Outcome
The proportion of patients that adhere to TRE will be estimated with the corresponding exact binomial 90% confidence interval.
Conditions Studied
Interventions
- OTHER Time Restricted Eating
Study Locations (1)
Pennsylvania
- Sidney Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2022-07-28 |
| Est. Completion | 2027-05-01 |
| Phase | NA |
What NCT05327608 shows while recruiting
NCT05327608 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 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 (82% lower).
The record links to 7 conditions, with Anatomic Stage III Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 1 intervention - of which Time Restricted Eating is the first listed.
NCT05327608 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05327608 about?
NCT05327608 is a clinical study titled "Neoadjuvant Breast Cancer Time Restricted Eating". A phase II study to evaluate an innovative approach of following time restricted eating (TRE) in patients with HER2- negative breast cancer who will start neoadjuvant chemotherapy (NCT) for a new diagnosis of stage I-III breast cancer. Participants at baseline will have a body mass index (BMI) of (2...
What is the current status of trial NCT05327608?
This trial is currently recruiting. It is a NA study. The enrollment target is 55 participants. The study started on 2022-07-28. Estimated completion is 2027-05-01.
What conditions does trial NCT05327608 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, Invasive Breast Carcinoma, HER2-Negative Breast Carcinoma.
What interventions are being tested in trial NCT05327608?
The interventions under investigation include: Time Restricted Eating (OTHER).
Who is sponsoring clinical trial NCT05327608?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05327608 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05327608's enrollment target sits among peer trials
55 49th of 84 higher than 36 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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