Time-Restricted Eating and Cancer: Clinical Outcomes, Mechanisms, and Moderators
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether changing meal times can reduce cancer treatment side effects, change how tumors behave, or affect mood and behavior. It is for adults with certain types of breast or rectal cancer who are getting treatment aimed at a cure.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 18 or older, of any sex, gender, race, or ethnic background.
- Cancer confirmed by a tissue test: stage II, III, or IV rectal cancer that can be treated for a cure; or stage I, II, or III HER2-positive or triple-negative breast cancer being treated for a cure. These breast cancer types are based on proteins found on cancer cells.
- Body mass index (BMI), a measure based on height and weight, of at least 18.5.
- For breast cancer: getting treatment before surgery aimed at a cure.
- For rectal cancer: getting the full planned course of treatment before surgery, including the drug 5-fluorouracil, aimed at a cure.
- Have completed no more than 4 weeks of treatment before surgery when joining the study.
- Willing and able to follow study tests, visits, and rules.
Who can't join
- Had cell-killing chemotherapy within 12 months before the cancer diagnosis, an allergic reaction to a treatment drug, or any past radiation treatment to the pelvis.
- Have another active cancer, except non-melanoma skin cancer or cervical cancer that has not spread beyond the surface cells.
- Had a hole in the stomach or intestines within the past 12 months, or have a bowel disorder with severe or quickly worsening symptoms not caused by the current cancer.
- Receive nutrition through a vein or feeding tube, or use a similar nutrition supplement during the study.
- Have uncontrolled heart failure rated class III or higher, or severe nerve damage rated grade 3 or higher.
- Are in a study of an experimental drug or device, or were in one within 4 weeks before the first treatment dose; or are pregnant or breastfeeding.
- Work overnight more than once a week on average, or already limit all eating to a period shorter than 10 hours on most days.
- Have a mental health or substance use disorder that would prevent following study rules, or another health condition or abnormal lab result that study doctors believe could affect safety or the accuracy of study results.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 sites (2)
AL
- The University of Alabama at Birmingham · Birmingham, AL 35294Courtney M Peterson, PhD · Study contactCourtney M Peterson, PhD · Principal investigatorMore trials in Birmingham
CA
- Cedars-Sinai Medical Center · West Hollywood, CA 90048Nathalie Nguyen, MPH · Study contactMore trials in West Hollywood