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NCT Number: NCT07524218

Effect of Meal Timing During Adjuvant Treatment for Cancer

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.

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Key information

Conditions

Cancer Behavior Fasting Feeding Behavior Intermittent Fasting Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars Sinai Medical Center (CSMC)

Los Angeles, California, 90048, United States

Location contact

Jane Figueiredo

CONTACT

[email protected]

(310) 423-2746

Jane Figueiredo, PhD

PRINCIPAL_INVESTIGATOR

About this study

Participants will be randomized to one of two groups:

  • Time-restricted eating (TRE) (8-hour daily eating period, starting 1-3 hours after waking up), OR
  • A control group defined as a ≥12-hour daily eating period.

Participants are assigned to either TRE (8-hour daily eating period, starting 1-3 hours after waking up) or a control group defined as a ≥12-hour daily eating period. Their randomized meal assignment arm begins no later than 1-2 week after they begin cancer treatment and ends at end of treatment (resection if indicated). This is a period of approximately 6 months.

During this time, participants will be asked to record the time they started and finished eating every day. Electronic reminders and weekly calls to the participants will be made by study staff who maintain records of patient's meal timing. Researchers will time the TRE schedules relative to sleep time (not time of day), which is a reasonable proxy for circadian time. The control group was designed to mimic typical eating habits in the U.S., as data from NHANES suggest that the median American eats over a 12.5-hour period each day. Aside from these general prescriptions, no set number of snacks, meals, or calories will be prescribed. Instead, researchers will measure how TRE affects self-reported mealtimes, meal frequency, and food intake through a combination of daily adherence surveys, 3-day food records and continuous glucose monitoring (CGM).

Participants will receive weekly one-on-one nutrition counseling during the first month and then monthly counseling sessions thereafter. Participants will complete questionnaires at intake and subsequent follow-up assessments. Blood and stool samples will also be collected from participants throughout the study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Time-restricted eating

Behavioral

Participate in time-restricted eating plan

Questionnaire Administration

Other

Complete questionnaire

Biospecimen Collection

Procedure

Undergo collection of blood and stool

Health Coaching

Behavioral

Receive nutrition counseling

Primary outcomes

  1. 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)

    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.

  2. Treatment Delivery: Relative dose intensity (RDI)

    Time frame: At end of intervention (at approximately 6 months)

    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.

  3. 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)

Secondary outcomes

  1. Clinician-reported CTCAE grade ≥3 toxicities

    Time frame: Baseline through end of intervention (at approximately 6 months)

  2. Clinician-reported Toxicity Index

    Time frame: Baseline through end of intervention (at approximately 6 months)

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

    Time frame: 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)

    Change in quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), a validated 30-item instrument measuring global health status/quality of life, functional domains (physical, role, emotional, cognitive, and social functioning), and symptom domains. Scores are linearly transformed to a 0-100 scale according to standard scoring guidelines. For global health status and functional scales, higher scores indicate better functioning or quality of life; for symptom scales, higher scores indicate greater symptom burden.

  4. PROMIS Anxiety

    Time frame: 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)

    Change in anxiety measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety short form. Scores are standardized T-scores (mean = 50, standard deviation = 10). Higher scores indicate greater anxiety.

  5. PROMIS Fatigue

    Time frame: 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)

    Change in fatigue measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue short form. Scores are standardized T-scores (mean = 50, standard deviation = 10). Higher scores indicate greater fatigue.

  6. PROMIS Physical Function

    Time frame: 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)

    Change in physical function measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function short form. Scores are standardized T-scores (mean = 50, standard deviation = 10). Higher scores indicate better physical function.

  7. UCLA Loneliness Scale

    Time frame: 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)

    Change in perceived loneliness assessed using the UCLA Loneliness Scale. Scores are calculated by summing item responses, with higher scores indicating greater perceived loneliness.

  8. Munich Chronotype Questionnaire (MCTQ)

    Time frame: 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)

    Change in chronotype assessed using the Munich Chronotype Questionnaire. Chronotype is derived as mid-sleep time on free days, corrected for sleep debt (MSFsc), with later times indicating more evening preference.

  9. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 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)

    Change in sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI). The global score is calculated from seven components, with higher scores indicating poorer sleep quality.

  10. Appetite Questionnaire

    Time frame: 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)

    Change in appetite assessed using a validated appetite questionnaire. Scores reflect patient-reported appetite levels, with higher scores indicating greater appetite (or specify direction if opposite).

  11. Dutch Eating Behavior Questionnaire (DEBQ)

    Time frame: 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)

    Change in eating behaviors assessed using the Dutch Eating Behavior Questionnaire (DEBQ), including emotional eating, external eating, and restrained eating subscales. Higher scores indicate greater endorsement of the respective eating behavior.

  12. Fasting Insulin

    Time frame: 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)

    Change in fasting insulin levels measured from blood samples

  13. Fasting Glucose

    Time frame: 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)

    Change in fasting glucose levels measured from blood samples.

  14. IGF-1

    Time frame: 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)

    Change in circulating IGF-1 levels measured from blood samples.

  15. Total Cholesterol

    Time frame: 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)

    Change in total cholesterol levels measured from blood samples.

  16. LDL Cholesterol

    Time frame: 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)

    Change in low-density lipoprotein (LDL) cholesterol levels measured from blood samples.

  17. HDL Cholesterol

    Time frame: 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)

    Change in high-density lipoprotein (HDL) cholesterol levels measured from blood samples.

  18. Triglycerides

    Time frame: 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)

    Change in triglyceride levels measured from blood samples.

  19. C-Reactive Protein (CRP)

    Time frame: 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)

    Change in CRP levels measured from blood samples as a marker of systemic inflammation.

  20. Vitamin D

    Time frame: 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)

    Change in circulating 25-hydroxyvitamin D levels measured from blood samples.

  21. Changes in sleep and physical activity patterns measured by wrist actigraphy

    Time frame: Baseline and end of treatment (approximately 6 months)

    Sleep and physical activity patterns will be assessed using wrist actigraphy to measure parameters such as sleep duration, sleep timing, sleep efficiency, and activity levels.

  22. Change in gut microbiome composition and diversity from stool samples

    Time frame: Baseline, mid-treatment (approximately 3 months), and end of treatment (approximately 6 months)

    Change in stool-derived gut microbiome composition, including relative abundance of microbial taxa, and microbial diversity indices (e.g., alpha diversity such as Shannon index), measured using sequencing-based methods (e.g., 16S rRNA sequencing and metagenomics).

  23. Changes in glucose patterns measured using continuous glucose monitoring (CGM)

    Time frame: Baseline and end of treatment (approximately 6 months)

    Glucose levels will be continuously monitored using a wearable continuous glucose monitor to assess changes in glycemic patterns associated with the intervention.

Study contacts

Contact information is provided by the study sponsor or research team.

Jane Figueiredo, PhD

CONTACT

[email protected]

(310) 423-2746

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • Alaska Native Medical Center
  • Alaska Native Tribal Health Consortium
  • Cedars-Sinai Medical Center
  • National Cancer Institute (NCI)

Registry information

Official study title

Effect of Meal Timing During Adjuvant Treatment for Cancer: A Randomized Clinical Trial

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Apr 13, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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