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

NCT01802346 | Active Not Recruiting DMC

• 2 other identifiers: 0S-10-3NCI-2013-00414
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 3

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Rate of chemotherapy-related toxicity

  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.

  Up to 12 weeks

Secondary Outcomes (1)

• Tumor response

  Up to 12 weeks

Study Arms (2)

Arm I (low-calorie diet)

EXPERIMENTAL

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.

Dietary Supplement: dietary intervention; Other: laboratory biomarker analysis

Arm II (normal diet)

ACTIVE COMPARATOR

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.

Procedure: nutritional support; Other: laboratory biomarker analysis

Interventions

dietary intervention DIETARY_SUPPLEMENT

Consume a low-calorie diet

Also known as: Dietary Modification, intervention, dietary

Arm I (low-calorie diet)

nutritional support PROCEDURE

Receive dietary advice

Also known as: nutritional assessment, nutritional care, support, nutritional

Arm II (normal diet)

laboratory biomarker analysis OTHER

Correlative studies

Arm I (low-calorie diet); Arm II (normal diet)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• Mayo Clinic: collaborator
• University of Southern California: lead

Study Sites (3)

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

USC Norris Oncology/Hematology-Newport Beach

Newport Beach, California, 92663, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Prostatic Neoplasms

Interventions

Diet Therapy; Nutritional Support; Nutrition Assessment; Nutrition Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Darcy Spicer, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2013
• First Posted: March 1, 2013
• Study Start: January 29, 2013
• Primary Completion (Estimated): June 29, 2026
• Study Completion (Estimated): June 29, 2027
• Last Updated: December 5, 2025

Record last verified: 2025-12

Locations

US (3)