Neoadjuvant Breast Cancer Time Restricted Eating (NCT05327608)
Time Restricted Eating for Patients With HER2- Negative Breast Cancer Receiving Neoadjuvant Chemotherapy
🩺 Plain-English Summary (8th-Grade Level)
A phase II study to evaluate an innovative approach of following time restricted eating (TRE) in patients with early-stage 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.
Who can join: Review the eligibility criteria below.
Location: Sidney Kimmel Cancer Center at Thomas Jefferson University — Philadelphia, Pennsylvania
Age range: 18 Years
🧪 Interventions in This Study
- Time Restricted Eating (OTHER)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Sidney Kimmel Cancer Center at Thomas Jefferson University — Philadelphia, Pennsylvania
📞 Contact the Study Coordinator
Phone: (215) 600-9151
Email: ONCTrialNow@jefferson.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Anatomic Stage I Breast Cancer AJCC v8
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- Identifying Decision Making Needs for Older Adult Women With Stage I-III Breast Cancer Considering Neoadjuvant or Adjuvant Chemotherapy — Houston, Texas
- Treatment Effects on Development of Chemotherapy-Induced Peripheral Neuropathy in Patients With Cancer — Antioch, California
- Infertility Survey Among Reproductive Age Women With Gynecological and Breast Cancer — Houston, Texas
- Genetic Testing in Predicting Tumor Response in Patients With Stage I-III HER2 Negative Invasive Breast Cancer — Houston, Texas
- Phase III Study of 5tx vs 15tx of RT (X-rays or Protons) Including RNI in Breast Cancer Patients — Scottsdale, Arizona
Explore by condition: All Anatomic Stage I Breast Cancer AJCC v8 clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.