Effect of Meal Timing During Adjuvant Treatment for Cancer

NCT07524218 | Not Yet Recruiting DMC

• 3 other identifiers: RG11261311P50CA285275-01A1FHIRB21058
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

Time-restricted eating; Time restricted eating; Meal timing

Outcome Measures

Primary Outcomes (3)

• Patient-reported treatment-related toxicities: Average weekly scores

  Assessed via Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE v5) toxicities, which is administered weekly throughout intervention and therapy; average scores calculated at each time point, timed to oncologic treatment cycles.

  Assessed weekly from start of intervention through end of intervention (up to approximately 6 months)

• Treatment Delivery: Relative dose intensity (RDI)

  Relative dose intensity (RDI), defined as delivered/planned dose intensity, will be analyzed both as a continuous outcome (% of delivered vs planned) and as a binary outcome (≥85% vs. \< 85%). Regimen-level RDI will be calculated as the average across drugs or based on the dose-limiting agent.

  At end of intervention (at approximately 6 months)

• Treatment Delivery: Number of patients completing planned adjuvant therapy without unplanned dose reductions or delays

  At end of intervention (at approximately 6 monhts)

Secondary Outcomes (23)

• Clinician-reported CTCAE grade ≥3 toxicities

  Baseline through end of intervention (at approximately 6 months)

• Clinician-reported Toxicity Index

  Baseline through end of intervention (at approximately 6 months)

• Changes in quality of life (QOL): EORTC QLQ-C30

  Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)

• PROMIS Anxiety

  Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)

• PROMIS Fatigue

  Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)

Study Arms (2)

Time-restricted eating (TRE)

EXPERIMENTAL

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

Behavioral: Time-restricted eating; Other: Questionnaire Administration; Procedure: Biospecimen Collection; Behavioral: Health coaching

Control group

ACTIVE COMPARATOR

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

Other: Questionnaire Administration; Procedure: Biospecimen Collection; Behavioral: Health coaching

Interventions

Time-restricted eating BEHAVIORAL

Participate in time-restricted eating plan

Time-restricted eating (TRE)

Questionnaire Administration OTHER

Complete questionnaire

Control group; Time-restricted eating (TRE)

Biospecimen Collection PROCEDURE

Undergo collection of blood and stool

Control group; Time-restricted eating (TRE)

Health coaching BEHAVIORAL

Receive nutrition counseling

Control group; Time-restricted eating (TRE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• Alaska Native Medical Center: collaborator
• Alaska Native Tribal Health Consortium: collaborator
• National Cancer Institute (NCI): collaborator
• Cedars-Sinai Medical Center: collaborator

Study Sites (1)

Cedars Sinai Medical Center (CSMC)

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Neoplasms; Intermittent Fasting

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior

Study Officials

• Jane Figueiredo, PhD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

• Timothy Thomas, MD

  Alaska Native Tribal Health Consortium (ANTHC)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jane Figueiredo, PhD

CONTACT

(310) 423-2746; Jane.Figueiredo@cshs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 6, 2026
• First Posted: April 13, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): August 31, 2029
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)