This clinical trial compares time restricted eating to a more traditional eating schedule to improve response and reduce side effects for patients receiving treatment before surgery (neoadjuvant) for stage II-IV rectal cancer or stage I-III breast cancer. In some studies, various forms of fasting with chemotherapy have been shown to make tumors small and to improve long-term survival. Fasting can make the tumors cells more sensitive to chemotherapy while protecting healthy cells by increasing stress resistance, which can reduce side effects. Time restricted eating involves eating within a shorter window (8 hours) and fasting for the remainder of the day but involves no other dietary restrictions. Because of its simplicity, time restricted eating may be more sustainable than other fasting regimens. Time restricted eating may improve response and reduce side effects when compared to a more traditional eating schedule for patients receiving neoadjuvant treatment for stage II-IV rectal cancer or stage I-III breast cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06802172.
Locations matching your search criteria
United States
Alaska
Anchorage
Alaska Native Medical CenterStatus: Approved
Contact: Timothy K Thomas
Phone: 907-729-3095
PRIMARY OBJECTIVES:
I. Determine the effect of time restricted eating (TRE) during neoadjuvant treatment on treatment response, treatment-related toxicities, quality of life and adherence among Alaska Native patients with rectal or HER 2-positive or triple negative breast cancer.
II. Assess changes in biomarkers related to metabolic function, cancer, and deoxyribonucleic acid (DNA) damage before and during the TRE intervention and their associations with outcomes of interest.
III. Examine differences in clinical outcomes, adherence, and biomarkers across five racial and ethnic groups.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients engage in time restricted eating, starting their eating period each day 1-3 hours after waking up, completing all eating within the 8 hour period and fasting for the remaining 16 hours of the day, each day, starting within 4 weeks after beginning cancer treatment, up to end of chemotherapy treatment or at resection surgery if applicable, (approximately 6 months) in the absence of disease progression or unacceptable toxicity. Patients may receive nutrition counseling weekly for the first month then monthly thereafter. Patients undergo continuous glucose monitoring and wear an activity monitor on study and undergo blood sample collection throughout the study.
ARM II: Patients engage in typical eating habits, eating over a 12.5 hour period, each day, starting within 4 weeks after beginning cancer treatment, up to end of chemotherapy treatment or at resection surgery if applicable, (approximately 6 months) in the absence of disease progression or unacceptable toxicity. Patients may receive nutrition counseling weekly for the first month then monthly thereafter. Patients undergo continuous glucose monitoring and wear an activity monitor on study and undergo blood sample collection throughout the study.
After completion of study intervention, patients are followed up 6 months after resection surgery
Trial PhaseNo phase specified
Trial Typehealth services research
Lead OrganizationFred Hutch/University of Washington/Seattle Children's Cancer Consortium
Principal InvestigatorTimothy K Thomas
