Effect of Meal Timing During Cancer Treatment in Patients in Alaska: A Randomized Clinical Trial
Recruiting
N/AInterventional Study
Rectal Cancer Stage IIRectal Cancer Stage IIIBreast Cancer Stage IRectal Cancer Stage IVBreast Cancer Stage IIBreast Cancer Stage IIISolid Tumor Cancer
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
21 and older
Sex
Any
Study type
Interventional
Purpose
Other
Participants needed
100 (estimated)
Sponsor
Fred Hutchinson Cancer Center · Other
Who this trial is looking for
This trial is looking for people with breast or rectal cancer who are receiving treatment at the Alaska Native Medical Center. Participants will follow a specific meal-timing schedule to see if it helps their treatment and overall health.
Are You a Good Fit for This Trial?
You may be able to join if
I am 21 years or older.
I identify as Alaska Native or American Indian.
I have stage II, III, or IV rectal cancer.
I have stage I, II, or III HER2+ or triple-negative breast cancer.
I have a body mass index (BMI) of at least 18.5.
I plan to receive more than 3 months of treatment.
I can give informed consent.
I have completed 4 weeks or less of my treatment before enrolling.
You may not be able to join if
I had chemotherapy within the last 12 months.
I have an active second cancer that needs treatment.
I have had any pelvic radiation therapy in the past.
I have a history of severe bowel disorders.
I am currently pregnant or breastfeeding.
I have severe psychiatric or cognitive disorders.
I participate in overnight shift work more than once a week.
I am allergic to any treatment used in the trial.
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 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 Triba…
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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)
* Histologically confirmed HER2+ or triple neg…
Inclusion Criteria:
* 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)
* Histologically confirmed HER2+ or triple negative breast cancer stage I, II, or III, per AJCC criteria (neoadjuvant)
* Histologically or cytologically confirmed solid tumor (adjuvant)
* BMI≥18.5 kg/m2
* Plan to receive neoadjuvant or adjuvant therapy
* Planned duration of neoadjuvant or systemic adjuvant therapy for \>3 months to allow sufficient time to assess impact of intervention
* Must have capacity to give informed consent
* Willing and able to adhere to the assessments, visit schedules, prohibitions, and restrictions
* Has completed ≤ 4 weeks of neoadjuvant or adjuvant treatment prior to study enrollment
* Score of \< 4 on U.S. Household Food Security Survey Module: Six-Item Short Form OR if score \>5, have clearance from dietitian
Exclusion Criteria:
* 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
* 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 CHF defined as 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
* Unstable psychiatric, sleep, or circadian conditions (common conditions such as sleep apnea and depression are acceptable as long as they are stabilized and not rapidly worsening)
* Pregnant or breastfeeding
* Currently perform overnight shift work \>1 day/week
* Strictly adhering to a \<10-hour eating window on most days
* Severe psychiatric, cognitive, or substance misuse disorders or social conditions that would interfere with adherence to study procedures.
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