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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
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

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
USC / Norris Comprehensive Cancer Center
Coordinator of this site? Confirm its status
Los AngelesUnited StatesUnknown status
USC Norris Oncology/Hematology-Newport Beach
Coordinator of this site? Confirm its status
Newport BeachUnited StatesUnknown status
Mayo Clinic - Rochester
Coordinator of this site? Confirm its status
RochesterUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.