Status:
RECRUITING
Time-Restricted Eating and Cancer: Clinical Outcomes, Mechanisms, and Moderators
Lead Sponsor:
Cedars-Sinai Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
University of Alabama at Birmingham
Conditions:
Colorectal Cancer
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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.
Detailed Description
Combining fasting with chemotherapy is known to cause complete tumor regression and long-term survival in animal models. According to the Differential Stress Sensitization (DSS) theory, acute fasting ...
Eligibility Criteria
Inclusion
- Any sex/gender of any ethnic/racial background
- Age greater than or equal to 18 years
- Histologically-confirmed rectal cancer stage II, III, or IV (if curative) or human epidermal growth factor receptor 2-positive (HER2+) or triple negative breast cancer stage I, II, or III (only if definitive intent) per American Joint Committee on Cancer (AJCC) criteria
- BMI 18.5 kg/m2 or greater
- Receiving either neoadjuvant therapy with curative intent (breast cancer patients) or total neoadjuvant therapy with a 5-fluorouracil-based regimen and curative intent (rectal cancer patients)
- Has completed ≤ 4 weeks of neoadjuvant treatment prior to study enrollment
- Willing and able to adhere to the assessments, visit schedules, prohibitions, and restrictions
Exclusion
- History of cytotoxic chemotherapy less than or equal to 12 months prior to rectal or breast cancer diagnosis
- Allergic reaction to any of the treatment agents
- Any prior pelvic radiotherapy
- Currently active second malignancy other than non-melanoma skin cancers or cervical carcinoma in situ
- History of GI perforation ≤12 months prior to enrollment
- History of predisposing colonic or small bowel disorders with severe or rapidly worsening symptoms (not related to current cancer symptoms)
- Receiving any parenteral nutrition or enteral (tube) feeding or using similar nutritional supplement during the study period
- History of uncontrolled congestive heart failure defined as ew York Heart Association Class (NYHA) Class III or greater
- Pre-existing grade ≥3 neuropathy
- Currently participating in or has participated in a study of an investigational agent or investigational device ≤4 weeks of the first dose of treatment
- Pregnant or breastfeeding
- Currently perform overnight shift work more than one day/week on average
- Strictly adhering to a \<10-hour eating window on most days
- Known psychiatric or substance abuse disorders that would interfere with adhering to the requirements of the trial
- Medical condition or laboratory abnormality that could impact participant safety or data validity, in the opinion of the medical investigators.
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT04722341
Start Date
January 1 2022
End Date
December 31 2026
Last Update
December 16 2025
Active Locations (2)
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1
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Cedars-Sinai Medical Center
West Hollywood, California, United States, 90048