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

NCT ID: NCT01802346

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-29
• Study Completion Date: 2027-06-29

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.

Conditions

Breast Cancer; Hormone-resistant Prostate Cancer; Recurrent Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Arm I (low-calorie diet)

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.

Group Type: EXPERIMENTAL

dietary intervention

Intervention Type: DIETARY_SUPPLEMENT

Consume a low-calorie diet

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Arm II (normal diet)

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.

Group Type: ACTIVE_COMPARATOR

nutritional support

Intervention Type: PROCEDURE

Receive dietary advice

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Interventions

dietary intervention

Consume a low-calorie diet

Intervention Type: DIETARY_SUPPLEMENT

nutritional support

Receive dietary advice

Intervention Type: PROCEDURE

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

Dietary Modification; intervention, dietary; nutritional assessment; nutritional care; support, nutritional

Eligibility Criteria

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)

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Darcy Spicer, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

USC Norris Oncology/Hematology-Newport Beach

Newport Beach, California, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

NCI-2013-00414

Identifier Type: REGISTRY

Identifier Source: secondary_id

0S-10-3

Identifier Type: -

Identifier Source: org_study_id