Clinical trial NCT05359848: A Pilot, Feasibility Study of Intermittent Caloric Restriction Plus Plant-based Diet in Cancer Patients Receiving Chemotherapy
Official title: A Pilot, Feasibility Study of Intermittent Caloric Restriction Plus Plant-based Protein Diet in Cancer Patients Receiving Chemotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Medical Oncology
Integrative Oncology
Medical Nutrition Therapy
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2022-05-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The feasibility of intermittent caloric restriction plus a plant-based diet in cancer patients receiving chemotherapy
timeFrame: 12 Months
measure: The feasibility of intermittent caloric restriction plus a plant-based diet in cancer patients receiving chemotherapy
timeFrame: 12 Months
measure: The feasibility of intermittent caloric restriction plus a plant-based diet in cancer patients receiving chemotherapy
timeFrame: 12 Months
Secondary outcomes:
measure: To obtain preliminary evidence of clinical efficacy of the combination of chemotherapy and intermittent caloric restriction
timeFrame: 12 Months
measure: To obtain preliminary evidence of clinical efficacy of the combination of chemotherapy and intermittent caloric restriction
timeFrame: 12 Months
measure: To obtain preliminary evidence of clinical efficacy of the combination of chemotherapy and intermittent caloric restriction
timeFrame: 12 Months
Other outcomes:
measure: The safety and tolerability of the combination of chemotherapy and caloric restriction
timeFrame: 12 Months
Locations:
city: Buffalo
country: United States
facility: University at Buffalo / Great Lakes Cancer Care
state: New York
city: Buffalo
country: United States
facility: University at Buffalo / Great Lakes Cancer Care
state: New York
Study officials:
References: