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NCT00908791 · ClinicalTrials.gov registry record · Early Phase 1
Proof of Principle Trial to Determine if Nutritional Supplement Conjugated Linoleic Acid (CLA) Can Modulate the Lipogenic Pathway in Breast Cancer Tissue
A Early Phase 1 study of Breast Cancer, sponsored by Dartmouth-Hitchcock Medical Center.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT00908791: Completed Early Phase 1 study of Breast Cancer, sponsored by Dartmouth-Hitchcock Medical Center.
NCT00908791 is a Early Phase 1 study of Breast Cancer that has completed, run by Dartmouth-Hitchcock Medical Center. The registered enrollment target is 24 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00908791, a Early Phase 1 study of Breast Cancer, has completed, sponsored by Dartmouth-Hitchcock Medical Center.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
Conjugated Linoleic Acid (CLA) is obtained in the human diet by consumption of foods containing ruminant fat. Milk and dairy products have shown the highest amounts of CLA. Clarinol (CLA), is considered a natural supplement and is not regulated by the Food and Drug Administration (FDA). CLA is known to inhibit proliferation of human breast cancer cells and tumors in rodent breast cancer models and reduced Spot 14 (THRSP, S14) and Fatty Acid Synthase (FASN) gene expression in breast cancer cells and tht the two major CLA isomers used in nutritional supplements (C9, t11 and t10, c12) were equipotent in reducing breast cancer cell growth. This study looks at the hypothesis that S14 expression is decreased by CLA and will characterize the major pharmacodynamic (PD) effects of CLA in newly diagnosed Breast cancer patients on Tumor tissue lipogenic pathway. FASN, S14 and Lipoprotein Lipase (LPL), Ki67 and apoptotic index expression will be assessed by quantitative immunohistochemistry (IHC) in initial breast cancer biopsies and compared to that in resected breast tumor tissue after the study subject has been taking CLA for ten to twenty-eight days. Tissue from adjacent breast adipocytes will also be analyzed to determine whether adipose tissue effects can serve as a surrogate marker for those in tumor tissue. A sample of the original biopsy will be compared to the tumor resection sample to determine the levels of CLA in the breast cancer cells.
Primary Outcome
To determine whether ≥ 10 days of CLA consumption suppresses Spot 14 expression in breast cancer tissue in vivo. The staining intensities scoring system used is: no immuostaining (0), weak staining (1), and strong staining (2). The scoring system used objectively and quantitatively assesses the expression of Spot 14, fatty acid synthase, and lipoprotein lipase using the image processing and analysis software Image-Pro Plus™ (MediaCybernetics).
Conditions Studied
Interventions
- DRUG Conjugated Linoleic Acid (CLA)
Study Locations (1)
New Hampshire
- Dartmouth Hitchcock Medical Center, Norris Cotton Cancer Center - Lebanon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2009-06 |
| Est. Completion | 2013-03 |
| Phase | Early Phase 1 |
What the finished NCT00908791 record still lists
NCT00908791 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Conjugated Linoleic Acid (CLA) is the first listed.
NCT00908791 reports a single indexed study location in New Hampshire.
Frequently Asked Questions
What is clinical trial NCT00908791 about?
NCT00908791 is a clinical study titled "Proof of Principle Trial to Determine if Nutritional Supplement Conjugated Linoleic Acid (CLA) Can Modulate the Lipogenic Pathway in Breast Cancer Tissue". Conjugated Linoleic Acid (CLA) is obtained in the human diet by consumption of foods containing ruminant fat. Milk and dairy products have shown the highest amounts of CLA. Clarinol (CLA), is considered a natural supplement and is not regulated by the Food and Drug Administration (FDA). CLA is known...
What is the current status of trial NCT00908791?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 24 participants. The study started on 2009-06. Estimated completion is 2013-03.
What conditions does trial NCT00908791 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT00908791?
The interventions under investigation include: Conjugated Linoleic Acid (CLA) (DRUG).
Who is sponsoring clinical trial NCT00908791?
This trial is sponsored by Dartmouth-Hitchcock Medical Center, which has 427 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00908791 being conducted?
This trial has 1 study location across New Hampshire. 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 NCT00908791's enrollment target sits among peer trials
24 1042nd of 1224 higher than 170 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.
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