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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

Description

PRIMARY OBJECTIVES: 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 controls. OUTLINE: 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.

Phase

N/A

Inclusion and Exclusion Criteria

  • Histologically confirmed breast cancer for which chemotherapy with AC (doxorubicin plus cyclophosphamide) is being utilized in the neoadjuvant or adjuvant setting OR metastatic prostate adenocarcinoma for which Docetaxel will be administered
  • Body mass index (BMI) >= 18.5
  • Subjects do not need to have measurable or evaluable disease; chemotherapy may be administered in the neoadjuvant, adjuvant, or metastatic setting
  • Prior therapy:
  • Breast cancer subjects may not have received prior chemotherapy, with the exception of curative-intent chemotherapy for a separate malignancy more than 3 years ago
  • Prostate cancer subjects may have received prior treatment with metronomic cyclophosphamide as this is considered anti-angiogenic/immunomodulatory and not cytotoxic
  • Prostate cancer subjects may be receiving a 2nd course of docetaxel provided that ** The first course resulted in a PSA response (> 30% reduction in prostate specific antigen [PSA] and/or improvement in radiographic findings or pain) and the last dose was >= 9 months ago
  • Prior Radiotherapy is allowed, provided at least 2 weeks have elapsed from completion of radiotherapy to initiation of protocol treatment
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2x upper limit of normal (ULN)
  • Absolute neutrophil count (ANC) > 1500
  • Platelets (plts) > 90,000
  • Premenopausal women must have a negative pregnancy test and must agree to use barrier contraception throughout the study period

  • Diabetes Mellitus
  • Peripheral Neuropathy >= grade 1
  • Prior therapy with inhibitors of IGF-1
  • Concurrent use of somatostatin
  • Significant food allergies which would make the subject unable to consume the food provided (ex: shellfish, soy or egg allergy)

Sites

Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.

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