Controlled Low Calorie Diet in Reducing Side Effects and Increasing Response to Chemotherapy in Patients With Breast or Prostate Cancer

Korábbi kezelés

• Prior therapy with inhibitors of IGF-1
• Concurrent use of somatostatin

Más betegség

• Diabetes Mellitus
• Significant food allergies which would make the subject unable to consume the food provided (ex: shellfish, soy or egg allergy)

Egyéb

• Peripheral Neuropathy >= grade 1

• 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