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NCT05327608
Neoadjuvant Breast Cancer Time Restricted Eating
NA trial testing Time Restricted Eating in Anatomic Stage I Breast Cancer AJCC v8 in 55 participants. Currently enrolling.
1 May 2027
Quick facts
| Lead sponsor | Thomas Jefferson University |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 55 |
| Start date | 28 July 2022 |
| Primary completion | 1 May 2027 |
| Estimated completion | 1 May 2027 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Time Restricted Eating
Conditions studied
- Anatomic Stage I Breast Cancer AJCC v8 — all drugs for Anatomic Stage I Breast Cancer AJCC v8 →
- Anatomic Stage II Breast Cancer AJCC v8 — all drugs for Anatomic Stage II Breast Cancer AJCC v8 →
- Anatomic Stage III Breast Cancer AJCC v8 — all drugs for Anatomic Stage III Breast Cancer AJCC v8 →
- Breast Ductal Carcinoma in Situ — all drugs for Breast Ductal Carcinoma in Situ →
Sponsor
Thomas Jefferson University
Who can join
18 and older, any sex, with Anatomic Stage I Breast Cancer AJCC v8 or Anatomic Stage II Breast Cancer AJCC v8. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05327608
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
Other trials of Time Restricted Eating
Trials testing the same drug.
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- NCT07211217 — Time Restricted Eating (TRE) in Bipolar Disorder · NA · not yet recruiting
- NCT07259434 — Time Restricted Eating in Survivors Trial 2.0 · NA · not yet recruiting
- NCT06686667 — The Feasibility of Overnight Time Restricted Eating and Impact on Glucose Levels in Shift Workers · NA · completed
Other recruiting trials for Anatomic Stage I Breast Cancer AJCC v8
Currently open trials in the same condition.
- NCT07443943 — A Dietary Supplement (Resistant Potato Starch) for Reducing Musculoskeletal Symptoms in Individuals Planning to Receive · Phase 2 · recruiting
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- NCT06324240 — Personalized Vaccine Immunotherapy in Combination With Checkpoint Inhibitor for Treatment of Triple Negative Breast Canc · Phase 1 · recruiting
- NCT07407920 — Ph2 Study for Optimization of Adjunct Systemic Therapy in HER2+ Patients, MolecularPCR Trial · Phase 2 · active not recruiting
- NCT06876714 — ShortStop-HER2: 12 Months vs. 6 Months of HER2-targeted Medications for People With HER2+ Breast Cancer Who Had a Pathol · Phase 3 · recruiting
Other Thomas Jefferson University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05327608 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Thomas Jefferson University
- Last refreshed: 1 August 2025
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