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

Not Applicable

Active, not recruiting

• Conditions: Breast Cancer; Recurrent Prostate Cancer; Hormone-resistant Prostate Cancer
• Interventions: Dietary Supplement: dietary intervention; Procedure: nutritional support; Other: laboratory biomarker analysis

• Registration Number: NCT01802346
• Lead Sponsor: University of Southern California

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 used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Eating a special diet with low calories may reduce the side effects of chemotherapy and improve the response to treatment

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 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.

Study Timeline

• Study Start: 2013-01-29
• Study First Submitted: 2013-02-27
• Study First Submitted QC: 2013-02-27
• Study First Posted: 2013-03-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-18
• Primary Completion: 2025-01-29
• Study Completion: 2026-01-29

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 130

Inclusion 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

Exclusion Criteria

• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (low-calorie diet)	dietary intervention	Patients eat a special low-calorie diet during 3 days prior to chemotherapy, during the 12 weeks of chemotherapy, and 2 days 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.
Arm II (normal diet)	laboratory biomarker analysis	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.
Arm II (normal diet)	nutritional support	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.
Arm I (low-calorie diet)	laboratory biomarker analysis	Patients eat a special low-calorie diet during 3 days prior to chemotherapy, during the 12 weeks of chemotherapy, and 2 days 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.

Primary Outcome Measures

Name	Time	Method
Rate of chemotherapy-related toxicity	Up to 12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Tumor response	Up to 12 weeks	Measured using a summary statistic which includes Response Evaluation Criteria In Solid Tumors (RECIST) response, PSA response for men without measurable disease, pathologic complete response and clinical response for breast cancer patients. This rate will be compared between patients on the restricted diet and controls.

Trial Locations

Locations (3)

Mayo Clinic Rochester; 🇺🇸 Rochester, Minnesota, United States

USC Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States

USC Norris Oncology/Hematology-Newport Beach; 🇺🇸 Newport Beach, California, United States