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NCT00951158 · ClinicalTrials.gov registry record · Phase 1
A Molecular Pharmacodynamic Dose-titration Trial of Conjugated Linoleic Acid (CLA; Clarinol®) in Patients With Advanced Solid Tumors
A Phase 1 study, sponsored by Dartmouth-Hitchcock Medical Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
NCT00951158 is a Phase 1 study that was terminated before completion, run by Dartmouth-Hitchcock Medical Center. The registered enrollment target is 4 participants.
The verdict
NCT00951158, a Phase 1 study, was terminated before completion, sponsored by Dartmouth-Hitchcock Medical Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
Study Summary
It has become apparent that many cancers depend on specific fats (lipids) for their continued growth. Conjugated linoleic acid (CLA) is a safe, popular, and well-tolerated dietary supplement that promotes weight loss and loss of fat. CLA was recently shown to block the metabolism (uptake and production) of lipids required for growth of some cancers, resulting in killing of cancer cells. The investigators will conduct a clinical trial to test whether oral CLA blocks metabolism of lipids in patients with advanced cancers. Since the dose of CLA that may do this is not yet known, the investigators will start at a dose of CLA known to be tolerable and effective for weight loss. If this dose does not block lipid metabolism, the investigators will test higher doses in successive groups of patients until the investigators identify an effective dose, unless the investigators find that these higher doses cannot be tolerated. In order to verify that CLA is absorbed, it is necessary to measure CLA levels in blood before and after doses are given. Likewise, in order to verify that CLA blocks lipid metabolism, the investigators will need to obtain small samples of abdominal fat (and, in some patients, samples of tumors).
Interventions
- DIETARY_SUPPLEMENT Conjugated Linoleic Acid
- DRUG Conjugated Linoleic Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2010-03 |
| Est. Completion | 2013-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00951158
The ClinicalTrials.gov registry entry for NCT00951158 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dartmouth-Hitchcock Medical Center, which has 427 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Conjugated Linoleic Acid is the first listed.
NCT00951158 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00951158 about?
NCT00951158 is a clinical study titled "A Molecular Pharmacodynamic Dose-titration Trial of Conjugated Linoleic Acid (CLA; Clarinol®) in Patients With Advanced Solid Tumors". It has become apparent that many cancers depend on specific fats (lipids) for their continued growth. Conjugated linoleic acid (CLA) is a safe, popular, and well-tolerated dietary supplement that promotes weight loss and loss of fat. CLA was recently shown to block the metabolism (uptake and product...
What is the current status of trial NCT00951158?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2010-03. Estimated completion is 2013-06.
What interventions are being tested in trial NCT00951158?
The interventions under investigation include: Conjugated Linoleic Acid (DIETARY_SUPPLEMENT), Conjugated Linoleic Acid (DRUG).
Who is sponsoring clinical trial NCT00951158?
This trial is sponsored by Dartmouth-Hitchcock Medical Center, which has 427 total clinical trials registered on ClinicalTrials.gov.
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