Effect of Meal Timing During Cancer Treatment in Patients in Alaska: A Randomized Clinical Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorFred Hutchinson Cancer Center

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Time-restricted eating
  • Questionnaire Administration
  • Biospecimen Collection
  • Health coaching

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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