Status:
ACTIVE_NOT_RECRUITING
Controlled Low Calorie Diet in Reducing Side Effects and Increasing Response to Chemotherapy in Patients With Breast or Prostate Cancer
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
National Cancer Institute (NCI)
Mayo Clinic
Conditions:
Breast Cancer
Hormone-resistant Prostate Cancer
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
This randomized phase II trial studies how well a controlled low calorie diet works in reducing side effects and increasing response to chemotherapy in patients with breast or prostate cancer. Drugs u...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
January 29 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 29 2027
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT01802346
Start Date
January 29 2013
End Date
June 29 2027
Last Update
December 5 2025
Active Locations (3)
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1
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
2
USC Norris Oncology/Hematology-Newport Beach
Newport Beach, California, United States, 92663
3
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905