Trial record 9 of 73 for:    Open Studies | "nutritional support"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University of Southern California
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Southern California
ClinicalTrials.gov Identifier:
NCT01802346
First received: February 27, 2013
Last updated: September 9, 2014
Last verified: September 2014
  Purpose

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


Condition Intervention Phase
Breast Cancer
Hormone-resistant Prostate Cancer
Recurrent Prostate Cancer
Dietary Supplement: dietary intervention
Procedure: nutritional support
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Randomized, Phase II Clinical Trial of a Controlled Diet Prior to Selected Chemotherapy Treatment in Breast and Prostate Cancer to Evaluate the Impact on Toxicity and Efficacy

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • Rate of chemotherapy-related toxicity [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: Yes ]
    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:
  • Tumor response [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 120
Study Start Date: January 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Dietary Supplement: dietary intervention
Consume a low-calorie diet
Other Names:
  • Dietary Modification
  • intervention, dietary
Other: laboratory biomarker analysis
Correlative studies
Active Comparator: 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.
Procedure: nutritional support
Receive dietary advice
Other Names:
  • nutritional assessment
  • nutritional care
  • support, nutritional
Other: laboratory biomarker analysis
Correlative studies

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 castration-resistant 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01802346

Contacts
Contact: Yvette Viverette, R.N. 323-865-0459 Yvette.Viverette@med.usc.edu

Locations
United States, California
USC Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Kristy Watkins, R.N.    323-865-0452    kristy.watkins@med.usc.edu   
Principal Investigator: Tanya B. Dorff         
Sponsors and Collaborators
University of Southern California
Investigators
Principal Investigator: Tanya Dorff University of Southern California
  More Information

No publications provided

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT01802346     History of Changes
Other Study ID Numbers: 0S-10-3, NCI-2013-00414
Study First Received: February 27, 2013
Last Updated: September 9, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Prostatic Neoplasms
Breast Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 22, 2014