Actively Recruiting
Time-Restricted Eating and Cancer: Clinical Outcomes, Mechanisms, and Moderators
Led by Cedars-Sinai Medical Center · Updated on 2025-12-16
175
Participants Needed
2
Research Sites
260 weeks
Total Duration
On this page
Sponsors
C
Cedars-Sinai Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to test whether the timing of meals can improve treatment adverse events, influence tumor biology and alter a person's mood and behaviors.
CONDITIONS
Official Title
Time-Restricted Eating and Cancer: Clinical Outcomes, Mechanisms, and Moderators
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Any sex or gender and any ethnic or racial background
- Age 18 years or older
- Histologically confirmed rectal cancer stage II, III, or IV (if curative intent) or HER2-positive or triple negative breast cancer stage I, II, or III (only if definitive intent) per AJCC criteria
- Body mass index (BMI) of 18.5 kg/m2 or greater
- Receiving neoadjuvant therapy with curative intent (breast cancer) or total neoadjuvant therapy with a 5-fluorouracil-based regimen and curative intent (rectal cancer)
- Completed 4 weeks or less of neoadjuvant treatment before study enrollment
- Willing and able to follow assessments, visit schedules, and study requirements
You will not qualify if you...
- Received cytotoxic chemotherapy within 12 months prior to rectal or breast cancer diagnosis
- Allergic reaction to any treatment agents
- Previous pelvic radiotherapy
- Active second cancer other than non-melanoma skin cancer or cervical carcinoma in situ
- History of gastrointestinal perforation within 12 months before enrollment
- Severe or rapidly worsening predisposing colonic or small bowel disorders unrelated to current cancer symptoms
- Receiving parenteral nutrition, enteral feeding, or similar supplements during the study
- History of uncontrolled congestive heart failure (NYHA Class III or greater)
- Pre-existing grade 3 or higher neuropathy
- Participation in another investigational drug or device study within 4 weeks before first treatment dose
- Pregnant or breastfeeding
- Working overnight shifts more than one day per week on average
- Strictly following a less than 10-hour eating window on most days
- Psychiatric or substance abuse disorders that interfere with study adherence
- Medical conditions or lab abnormalities that could affect safety or data validity as judged by investigators
AI-Screening
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Trial Site Locations
Total: 2 locations
1
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
Cedars-Sinai Medical Center
West Hollywood, California, United States, 90048
Actively Recruiting
Research Team
N
Nathalie Nguyen, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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