NCT01802346Active, not recruiting
Controlled Low Calorie Diet in Reducing Side Effects and Increasing Response to Chemotherapy in Patients With Breast or Prostate Cancer
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
Source: ClinicalTrials.gov · Last updated 5 Jun 2026
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 130 (actual)
- First submitted
- 27 Feb 2013
- Start date
- 29 Jan 2013
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- University of Southern California
- Diseases
- Prostate cancer
- NCT number
- NCT01802346
What you commit to
- Study type: Interventional
- Participants enrolled: 130
- From 29 Jan 2013 to the primary completion date, 31 Dec 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior therapy with inhibitors of IGF-1
- Concurrent use of somatostatin
Other illness
- Diabetes Mellitus
- Significant food allergies which would make the subject unable to consume the food provided (ex: shellfish, soy or egg allergy)
Other
- Peripheral Neuropathy \>= grade 1
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| USC / Norris Comprehensive Cancer Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| USC Norris Oncology/Hematology-Newport Beach Coordinator of this site? Confirm its status | Newport Beach | United States | Unknown status |
| Mayo Clinic - Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.