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NCT01802346 · ClinicalTrials.gov registry record · NA
Controlled Low Calorie Diet in Reducing Side Effects and Increasing Response to Chemotherapy in Patients With Breast or Prostate Cancer
A NA study of Breast Cancer and Recurrent Prostate Cancer, sponsored by University of Southern California.
- Active
- Registry status
- NA
- Development phase
- 130
- Enrollment target
- 3
- Study locations
NCT01802346: Active NA study of Breast Cancer and Recurrent Prostate Cancer, sponsored by University of Southern California.
NCT01802346 is a NA study of Breast Cancer and Recurrent Prostate Cancer that is active but no longer recruiting, run by University of Southern California. The registered enrollment target is 130 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (95% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01802346, a NA study of Breast Cancer and Recurrent Prostate Cancer, is active but no longer recruiting, sponsored by University of Southern California.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 130 participants
- Enrollment target
- 3
- Study locations
Study 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
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER laboratory biomarker analysis
- DIETARY_SUPPLEMENT dietary intervention
- PROCEDURE nutritional support
Study Locations (3)
California
- USC Norris Comprehensive Cancer Center - Los Angeles
- USC Norris Oncology/Hematology-Newport Beach - Newport Beach
Minnesota
- Mayo Clinic Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2013-01-29 |
| Est. Completion | 2027-06-29 |
| Phase | NA |
What the registry record for NCT01802346 still lists
NCT01802346 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (95% lower).
The record links to 3 conditions, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which laboratory biomarker analysis is the first listed.
NCT01802346 reports a single indexed study location in California, Minnesota.
Frequently Asked Questions
What is clinical trial NCT01802346 about?
NCT01802346 is a clinical study titled "Controlled Low Calorie Diet in Reducing Side Effects and Increasing Response to Chemotherapy in Patients With Breast or Prostate Cancer". 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...
What is the current status of trial NCT01802346?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 130 participants. The study started on 2013-01-29. Estimated completion is 2027-06-29.
What conditions does trial NCT01802346 study?
This clinical trial studies the following conditions: Breast Cancer, Recurrent Prostate Cancer, Hormone-Resistant Prostate Cancer.
What interventions are being tested in trial NCT01802346?
The interventions under investigation include: laboratory biomarker analysis (OTHER), dietary intervention (DIETARY_SUPPLEMENT), nutritional support (PROCEDURE).
Who is sponsoring clinical trial NCT01802346?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01802346 being conducted?
This trial has 3 study locations across California, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01802346's enrollment target sits among peer trials
130 489th of 1224 higher than 730 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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