A Pilot, Feasibility Study of Intermittent Caloric Restriction Plus Plant-based Diet in Cancer Patients Receiving Chemotherapy

Study Overview
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Brief Summary
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Caloric restriction may alter the response to chemotherapy induced stress response and enhance its antitumor effect. This study intends to use an intermitted caloric restriction protocol with alternate days before the chemotherapy administration to enhance the cytotoxic effect generated by standard treatment of cancer.

Detailed Description
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This pilot trial will provide preliminary evidence that 1) intermittent caloric restriction and a plant-based diet is feasible in cancer patients; 2) intermittent caloric restriction and a plant-based diet can be safely combined with standard chemotherapy; and 3) intermittent caloric restriction and a plant-based diet may reduce the side effects but increase the antitumor effects of standard chemotherapy.

Official Title
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A Pilot, Feasibility Study of Intermittent Caloric Restriction Plus Plant-based Protein Diet in Cancer Patients Receiving Chemotherapy

Conditions
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Medical Nutrition Therapy, Medical Oncology, Integrative Oncology

Intervention / Treatment
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* Other: Diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Histologically documented, cancer patients who are eligible to receive cytotoxic chemotherapy. Life expectancy of at least 6 months Adults ≥ 18 years of age Adequate hematologic, renal, and liver function as evidenced by the following: White blood cell (WBC) ≥ 2,500 cells/μL Absolute neutrophil count (ANC) ≥ 1,000 cells/μL Platelet Count ≥ 100,000 cells/μL Hemoglobin (HgB) ≥ 9.0 g/dL Creatinine ≤ 2.0 mg/dL Total bilirubin ≤ 2 x upper limit of normal (ULN) Aspartate aminotransaminase (AST, SGOT) ≤ 2.5 x ULN Alanine aminotransaminase (ALT, SGPT) ≤ 2.5 x ULN Exclusion Criteria: • Eastern Cooperative Oncology Group (ECOG) performance status 2 or higher Treatment with any of the following medications or interventions within 28 days of registration: Systemic corticosteroids; however, use of inhaled, intranasal, and topical steroids is acceptable. High dose calcitriol [1,25(OH)2VitD] (i.e., > 7.0 μg/week) Any infection requiring parenteral antibiotic therapy or causing fever (temperature > 100.5°F or 38.1°C) within 1 week prior to registration A known allergy, intolerance, or medical contraindication to receiving the contrast dye required for the protocol-specified CT/MRI imaging Any medical intervention or other condition which, in the opinion of the Principal Investigator, could compromise adherence with study requirements or otherwise compromise the study's objectives

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Patients with cancer where SOC is represented by chemotherapy will be eligible for the study. After informed consent, eligible patients will be scheduled to the chemotherapy. Each cycle will be every 14, 21 or 28 days depending on the regimen. The diet intervention will commence 1 week prior to the first infusion (i.e. on Day -5 for regimens every 21-28 days, on Day-3 for regimens every 14 days) and will continue until the end of cycle 4 or 6 depending on the regimen in the neoadjuvant or adjuvant setting. For metastatic disease the dietary intervention will last until cycle 6 and not beyond
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Diet|Using dietary interventions as an adjuvant tool may represent an effective step toward advancing the treatment options of cancer. Dietary modifications can impact the growth and proliferation of tumors via multiple mechanisms|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The feasibility of intermittent caloric restriction plus a plant-based diet in cancer patients receiving chemotherapy | enrollment rate | 12 Months | 
| The feasibility of intermittent caloric restriction plus a plant-based diet in cancer patients receiving chemotherapy | drop-out rate | 12 Months | 
| The feasibility of intermittent caloric restriction plus a plant-based diet in cancer patients receiving chemotherapy | compliance with diet measured by self-reports | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To obtain preliminary evidence of clinical efficacy of the combination of chemotherapy and intermittent caloric restriction | objective response rate (partial + complete response) | 12 Months | 
| To obtain preliminary evidence of clinical efficacy of the combination of chemotherapy and intermittent caloric restriction | progression-free survival (PFS) | 12 Months | 
| To obtain preliminary evidence of clinical efficacy of the combination of chemotherapy and intermittent caloric restriction | overall survival (OS) | 12 Months |