Time-Restricted Eating and Cancer: Clinical Outcomes, Mechanisms, and Moderators
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.
Inclusion Criteria
- 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 Criteria
- 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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04722341.
Locations matching your search criteria
United States
Alabama
Birmingham
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 sensitizes tumor cells to the cytotoxic effects of
chemotherapy and radiation, while protecting healthy cells by increasing stress
resistance. These effects are believed to be largely mediated via the Insulin-like Growth
Factor (IGF-1) pathway. However, extended fasting can be challenging for patients and
poses undue health risks. A number of alternative intermittent fasting regimens have been
proposed to overcome the challenges of prolonged caloric restriction. One promising
approach is time-restricted eating (TRE), which involves eating within a period of 10
hours or less, followed by fasting for at least 14 hours daily. TRE does not involve
extended caloric restriction, and because of its simplicity, it may be more sustainable
than other fasting regimens. TRE improves several cardiometabolic endpoints independent
of calorie restriction in both animals and humans, including insulin sensitivity, blood
pressure, fat oxidation, and hunger. Our team's pilot and feasibility trials suggest that
TRE may also have anti-cancer effects: it decreases IGF-1 levels, reduces oxidative
stress, upregulates antioxidant defenses, and enhances autophagy. Moreover, our data
suggest TRE is sustainable, as participants were adherent 6.0 plus or minus 0.8 days/week
over a 14-week period. These findings lead to the following provocative question: Can TRE
reduce treatment-related toxicity, induce tumor regression, and improve both
patient-reported and clinical outcomes? We propose to conduct the largest randomized
controlled trial of any form of intermittent fasting in patients undergoing cancer
treatment. We focus on patients with localized rectal or breast cancer because it is one
of the few treatment paradigms in which tumor characteristics can be measured before and
after chemoradiation therapy.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationCedars Sinai Medical Center
- Primary ID15494
- Secondary IDsNCI-2022-09048, 1R01CA258222-01
- ClinicalTrials.gov IDNCT04722341