A Randomized, Phase II Clinical Trial of a Controlled Diet Prior to Selected Chemotherapy Treatment in Breast and Prostate Cancer to Evaluate the Impact on Toxicity and Efficacy
I. To obtain preliminary estimates of the impact of a restricted diet on toxicity and
efficacy of chemotherapy for breast and prostate cancer.
II. To evaluate the compliance with a controlled diet intervention.
III. To investigate changes in plasma insulin, glucose, insulin-like growth factor 1 (IGF1)
and IGF binding protein (IGFBP) levels in subjects who consume a restricted diet compared to
Patients are randomized to 1 or 2 treatment arms.
ARM I: Patients eat a special low-calorie diet during 3 days prior to chemotherapy, during
the 12 weeks of chemotherapy, and 24 hours after chemotherapy. Patients are provided with
all meals and all food to be consumed and maintain a diary of the food consumed and
appropriate amounts. Patients meet with the study dietician within 3 weeks of enrollment
and prior to, or on the day of, their first course of chemotherapy on study and at the start
of each subsequent course.
ARM II: Patients eat a normal diet and receive dietary advice which may include consultation
with a nutritionist. Patients maintain a diary of the food consumed and appropriate amounts.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Rate of chemotherapy-related toxicity
Occurrence of Grade 2+ non-hematologic symptomatic toxicity (fatigue, nausea and vomiting, anorexia, neuropathy, mucositis, cystitis, stomatitis), evaluated according to Common Terminology Criteria for Adverse Events version 4.0. The two arms will be compared, in terms of the proportion of patients with the occurrence of one of these toxicities.
Up to 12 weeks
USC/Norris Comprehensive Cancer Center
United States: Federal Government
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