Controlled Low Calorie Diet in Reducing Side Effects and Increasing Response to Chemotherapy in Patients With Breast or Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01802346|
Recruitment Status : Recruiting
First Posted : March 1, 2013
Last Update Posted : May 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Hormone-resistant Prostate Cancer Recurrent Prostate Cancer||Dietary Supplement: dietary intervention Procedure: nutritional support Other: laboratory biomarker analysis||Not Applicable|
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.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|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 :||January 29, 2013|
|Estimated Primary Completion Date :||January 29, 2020|
|Estimated Study Completion Date :||January 29, 2021|
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: laboratory biomarker analysis
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: laboratory biomarker analysis
- Rate of chemotherapy-related toxicity [ Time Frame: 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.
- Tumor response [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01802346
|Contact: Cheryl Kefauver, RN||323-865-0459||Cheryl.Kefauver@med.usc.edu|
|United States, California|
|USC Norris Comprehensive Cancer Center||Recruiting|
|Los Angeles, California, United States, 90033|
|Contact: Bartolo Santos, RN 323-409-4363 Bartolo.firstname.lastname@example.org|
|Principal Investigator: David I. Quinn, MD|
|USC Norris Oncology/Hematology‐Newport Beach||Recruiting|
|Newport Beach, California, United States, 92663|
|Contact: Kristy Massopust Kristy.Massopust@med.usc.edu|
|Principal Investigator: Diana Hanna, MD|
|United States, Minnesota|
|Mayo Clinic Rochester||Recruiting|
|Rochester, Minnesota, United States, 55905|
|Contact: Clinical Trials Office 507-538-7623|
|Principal Investigator:||David I Quinn, MD||University of Southern California|