Integrative Oncology, Medical Nutrition Therapy, Medical Oncology
Conditions
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.
Interventions
OTHERDiet
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
Sponsors
State University of New York at Buffalo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The feasibility of intermittent caloric restriction plus a plant-based diet in cancer patients receiving chemotherapy | 12 Months | enrollment rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To obtain preliminary evidence of clinical efficacy of the combination of chemotherapy and intermittent caloric restriction | 12 Months | objective response rate (partial + complete response) |
Countries
United States
Outcome results
None listed