The goal of this clinical trial is to test meal-timing as a novel and sustainable interventional approach during cancer treatment to improve therapeutic response and metabolic health in an understudied population. This clinical trial will enroll patients with rectal or breast cancer receiving neoadjuvant treatment at the Alaska Native Medical Center (ANMC), which is part of the Alaska Native Tribal Health Consortium (ANTHC).
A promising strategy for improving the efficacy of anticancer treatments and reducing associated toxicities involves combining treatment with fasting regimens. In pre-clinical and clinical studies, various forms of fasting have been shown to induce tumor regression and improve long-term survival. According to the differential stress sensitization theory, fasting is thought to sensitize tumor cells to the cytotoxic effects of chemotherapy and radiation, while protecting healthy cells by increasing stress resistance. While healthy cells slow their growth and become more stress resistant in response to fasting, cancer cells cannot survive in nutrient-deficient environments; although the underlying mechanisms are not fully understood. However, extended water-only fasting can be challenging for patients and poses undue health risks. Intermittent fasting, and specifically time-restricted eating (TRE), may offer a viable alternative. TRE involves eating within a shorter window (e.g., 8 hours) and fasting for the remainder of the day but involves no other dietary restrictions. Because of its simplicity, TRE may be more sustainable than other fasting regimens. TRE also improves several cardio-metabolic endpoints, including insulin sensitivity, which may also be beneficial during anticancer treatments.
Male or female
Self-identify as Alaska Native or American Indian person and eligible for care at the ANMC
Age≥21 years
Histologically confirmed rectal cancer stage II, III, or IV (if curative) per AJCC criteria (neoadjuvant)
History of cytotoxic chemotherapy ≤12 months prior to rectal or breast cancer diagnosis (neoadjuvant)
Allergic reaction to any of the treatment agents
Any prior pelvic radiotherapy
Active second malignancy (exceptions: non-melanoma skin cancers or cervical carcinoma in situ adequately treated) requiring systemic therapy
Parallel
Time-restricted eating
BehavioralParticipate in time-restricted eating plan
Questionnaire Administration
Other interventionComplete questionnaire
Biospecimen Collection
Procedure/SurgeryUndergo collection of blood and stool
Health coaching
BehavioralReceive nutrition counseling
Pathological Complete Response (pCR) rate
The pCR will be defined as an absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected rectal or breast specimen and all sampled regional lymph nodes. It will be treated as a binary variable.
Treatment-related toxicity
The Patient Reported Outcome-Common Terminology Criteria for Adverse Events (PRO-CTCAE v.5) measurement system will be used to measure treatment-related toxicities. The PRO-CTCAE will be administered on a weekly basis throughout the intervention and will calculate the average over all items for each time point. Surveys will be timed relative to the start of each oncologic treatment segment.
Treatment Delivery (RDI and Completion)
Chemotherapy, targeted therapy, immunotherapy and/or radiation data will be abstracted to calculate relative dose intensity (RDI--delivered ÷ planned dose intensity, mg/m²/week) for each drug, expressed continuously and dichotomized at ≥85%. Regimen-level RDI will be calculated as the average across drugs or based on the dose-limiting agent. We will also calculate the proportion of participants completing all planned cycles without unplanned reductions or delays.
Clinical Complete Response (cCR)
A cCR will be defined as the clinical absence of residual disease on physical examination, endoscopic examination, and/or repeat MRI imaging following completion of total neoadjuvant treatment.
Tumor volume
Standard of care CT and MRI images will be obtained at the time of diagnosis for staging. A repeat standard of care MRI imaging may be obtained prior to surgery to assess response to neoadjuvant therapy and to guide clinical and surgical management. Researchers will obtain routine clinical restaging scans from participants and use them to estimate changes in tumor volume between the two time points.
Objective response rate (ORR)
The ORR is defined as the percentage of people who have a partial response (defined as a decrease in tumor volume) or a complete response to treatment between enrollment and surgery.
Neoadjuvant rectal (NAR) score
The NAR score is a validated surrogate endpoint for oncologic outcomes used in rectal cancer clinical trials. It takes as input the pathologic nodal status and the clinical and pathologic T-stage.
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Fred Hutchinson Cancer Center
Lead sponsor
Alaska Native Tribal Health Consortium
Sponsor institution
National Cancer Institute (NCI)
Collaborator
Alaska Native Tribal Health Consortium
Collaborator
Alaska Native Medical Center
Collaborator
Cedars-Sinai Medical Center
Collaborator
