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

Sponsor
University of Southern California (Other)
Overall Status
Recruiting
CT.gov ID
NCT01802346
Collaborator
National Cancer Institute (NCI) (NIH), Mayo Clinic (Other)
120
Enrollment
3
Locations
2
Arms
132
Anticipated Duration (Months)
40
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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

Condition or DiseaseIntervention/TreatmentPhase
  • Dietary Supplement: dietary intervention
  • Procedure: nutritional support
  • Other: laboratory biomarker analysis
N/A

Detailed Description

PRIMARY OBJECTIVES:
  1. To obtain preliminary estimates of the impact of a restricted diet on toxicity and efficacy of chemotherapy for breast and prostate cancer.

  2. To evaluate the compliance with a controlled diet intervention.

  3. 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 Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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
Actual Study Start Date :
Jan 29, 2013
Anticipated Primary Completion Date :
Jan 29, 2023
Anticipated Study Completion Date :
Jan 29, 2024

Arms and Interventions

ArmIntervention/Treatment
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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1USC Norris Comprehensive Cancer CenterLos AngelesCaliforniaUnited States90033
    2USC Norris Oncology/Hematology-Newport BeachNewport BeachCaliforniaUnited States92663
    3Mayo Clinic RochesterRochesterMinnesotaUnited States55905

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: David I Quinn, MD, University of Southern California

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Southern California
    ClinicalTrials.gov Identifier:
    NCT01802346
    Other Study ID Numbers:
    • 0S-10-3
    • NCI-2013-00414
    First Posted:
    Mar 1, 2013
    Last Update Posted:
    Nov 18, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 18, 2021