๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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 โค 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 โค12 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 โฅ3 neuropathy
* Currently participating in or has participated in a study of an investigational agent or investigational device โค4 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.
๐
What it tests
- Time-Restricted Eating (TRE)
- Control
The University of Alabama at Birmingham
Birmingham, United States
Cedars-Sinai Medical Center
West Hollywood, United States
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.