No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
175 (estimated)
Sponsor
Cedars-Sinai Medical Center · Other
Who this trial is looking for
This trial is looking for adults with certain types of colorectal or breast cancer. Participants will try a specific eating schedule while receiving their cancer treatment to see if it helps with treatment side effects and overall health.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old
I have been diagnosed with rectal cancer stage II, III, or IV or HER2+ or triple negative breast cancer stage I, II, or III
I have a BMI of 18.5 or higher
I am receiving neoadjuvant therapy for my cancer
I have completed 4 weeks or less of my treatment before joining the study
I am willing to follow the study's visit schedules and guidelines
You may not be able to join if
I have had chemotherapy within the last 12 months
I have an allergy to any treatment used in the study
I have had pelvic radiotherapy before
I currently have another active cancer
I have had gastrointestinal perforation in the last 12 months
I have a heart condition that is not controlled
I am pregnant or breastfeeding
I do shift work overnight more than once a week
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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City
State
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Status
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 …
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.
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