Effect of Meal Timing During Adjuvant Treatment for Cancer

ConditionCancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
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, 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Time-restricted eating

    Behavioral

    Participate in time-restricted eating plan

  • Questionnaire Administration

    Other intervention

    Complete questionnaire

  • Biospecimen Collection

    Procedure/Surgery

    Undergo collection of blood and stool

  • Health coaching

    Behavioral

    Receive nutrition counseling

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Time-restricted eating (TRE)Experimental treatment 4 interventions
Group B: Control groupActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Assessed weekly from start of intervention through end of intervention (up to approximately 6 months)
2

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.

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

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.

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)
4

PROMIS Anxiety

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.

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)

Other outcomes

Sponsors and contacts

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Fred Hutchinson Cancer Center

Lead sponsor

Cedars-Sinai Medical Center

Sponsor institution

National Cancer Institute (NCI)

Collaborator

Alaska Native Tribal Health Consortium

Collaborator

Alaska Native Medical Center

Collaborator

Cedars-Sinai Medical Center

Collaborator

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