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.
• Histologically documented, cancer patients who are eligible to receive cytotoxic chemotherapy.
Life expectancy of at least 6 months
Adults ≥ 18 years of age
White blood cell (WBC) ≥ 2,500 cells/μL
• Eastern Cooperative Oncology Group (ECOG) performance status 2 or higher
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
Single group
Diet
Other interventionUsing 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
The feasibility of intermittent caloric restriction plus a plant-based diet in cancer patients receiving chemotherapy
enrollment rate
The feasibility of intermittent caloric restriction plus a plant-based diet in cancer patients receiving chemotherapy
drop-out rate
The feasibility of intermittent caloric restriction plus a plant-based diet in cancer patients receiving chemotherapy
compliance with diet measured by self-reports
To obtain preliminary evidence of clinical efficacy of the combination of chemotherapy and intermittent caloric restriction
objective response rate (partial + complete response)
To obtain preliminary evidence of clinical efficacy of the combination of chemotherapy and intermittent caloric restriction
progression-free survival (PFS)
To obtain preliminary evidence of clinical efficacy of the combination of chemotherapy and intermittent caloric restriction
overall survival (OS)
The safety and tolerability of the combination of chemotherapy and caloric restriction
assessed using NCI CTCAE
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