Recruiting

Time-Restricted Eating

Sponsor:

Fred Hutchinson Cancer Center

Code:

NCT07524218

Conditions

Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Time-restricted eating

Questionnaire Administration

Biospecimen Collection

Health coaching

Study Details

Brief summary:

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, patient well-being and long-term metabolic health. In alignment with these priorities, we propose to focus on patients with histologically or cytologically confirmed solid tumors treated with curative-intent surgical resection and planned initiation of systemic adjuvant therapy (chemotherapy, targeted therapy, immunotherapy, and/or radiation per standard of care).

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.

Conditions

Cancer

Study ID

NCT07524218

Start date

Aug 12, 2026

Status verified date

Aug, 2026

Completion date

Aug 31, 2029

Anticipated

Primary completion date

Aug 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥18 years (no upper age limit)
  • Any sex or gender
  • Histologically or cytologically confirmed solid tumor treated with curative-intent surgical resection and planned initiation of systemic adjuvant therapy (chemotherapy, targeted therapy, immunotherapy, and/or radiation per standard of care)
  • BMI ≥18.5 kg/m2
  • Willing and able to adhere to the assessments, visit schedules, prohibitions, and restrictions

Exclusion Criteria:

  • No plan for systemic adjuvant therapy after surgery
  • Strictly adhering to a <10-hour eating window on most days
  • Regular overnight shift work (≥1 night shift per week)
  • Dependent on parenteral or enteral nutrition
  • Pregnant or breastfeeding
  • Active second malignancy requiring systemic therapy (exceptions: non-melanoma skin cancers or in situ cervical cancers adequately treated)
  • Severe psychiatric, cognitive, or social conditions that would interfere with adherence to study procedures

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Time-restricted eating (TRE)

Participants assigned to the TRE group will have an 8-hour daily eating period, starting 1-3 hours after waking up \[8 hours eating / 16 hours fasting per day (6+ days a week)\].

active comparator: Control group

Participants assigned to the control group are not time-restricted, and have a 12+ hour window of eating per day.

Interventions

Time-restricted eating

Participate in time-restricted eating plan

Questionnaire Administration

Complete questionnaire

Biospecimen Collection

Undergo collection of blood and stool

Health coaching

Receive nutrition counseling

Primary outcome measure

  • Patient-reported treatment-related toxicities: Average weekly scores [ Time Frame: Assessed weekly from start of intervention through end of intervention (up to approximately 6 months) ]
  • Treatment Delivery: Relative dose intensity (RDI) [ Time Frame: At end of intervention (at approximately 6 months) ]
  • Treatment Delivery: Number of patients completing planned adjuvant therapy without unplanned dose reductions or delays [ Time Frame: At end of intervention (at approximately 6 monhts) ]

Central Contacts and Locations

Central contacts

Locations

Cedars Sinai Medical Center (CSMC)

Recruiting

Los Angeles, California, United States, 90048

Contacts

Principal Investigator:

Jane Figueiredo, PhD

More Information

Sponsor

Fred Hutchinson Cancer Center

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

Keywords

  • Time-restricted eating
  • Time restricted eating
  • Meal timing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Fred Hutchinson Cancer Center on 2026-08-25.