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NCT00418678 · ClinicalTrials.gov registry record · Phase 4
A Phase IV Trial of Cesamet™ Given With Standard Antiemetic Therapy for Chemotherapy-induced Nausea and Vomiting
A Phase 4 study, sponsored by Veeda Oncology.
- Terminated
- Registry status
- Phase 4
- Development phase
- 16
- Enrollment target
NCT00418678 is a Phase 4 study that was terminated before completion, run by Veeda Oncology. The registered enrollment target is 16 participants.
The verdict
NCT00418678, a Phase 4 study, was terminated before completion, sponsored by Veeda Oncology.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 16 participants
- Enrollment target
Study Summary
This is a Phase IV, open-label, sequential treatment study in patients who are receiving standard chemotherapy for non-small cell lung cancer, breast cancer, or colorectal cancer. (See Section 4.2.1 for eligible treatment regimens.) The study will take place during the first 2 cycles of chemotherapy. Phase 1 of study: Prior to the first dose of chemotherapy, patients will be instructed on how to complete their patient diary, which will include a Visual Analogue Scale (VAS) for nausea and a VAS for pain. In addition, the diary will include a section to list their current pain medications (see Sample Patient Diary in Appendix I). After being instructed, patients will complete the VAS for nausea and for pain, as well as listing their current pain medications. Patients will then receive chemotherapy on Day 1 of Cycle 1 in combination with the pre-defined standard serotonin antagonist/corticosteroid regimen. Beginning on Day 2, the diary will be completed for 5 consecutive days (Days 2-6). Each day, patients will complete a diary entry pertaining to the preceding 24 hours. The entry will include the number and time of any emetic episodes, any antiemetic rescue medications used, VAS for nausea, and side effects of treatment. On the last day of the diary (Day 6), the entry will include the above daily parameters but will also include a VAS for pain. In addition, the patient will complete a diary entry pertaining to the 5-day study period that will include pain medications used. Patients will also complete the Functional Living Index - Cancer (FLIC) questionnaire (see Sample Function Living Index - Cancer questionnaire in Appendix II). Patients who either have at least one vomiting episode or at least one report of significant nausea (VAS \> 25 mm) during the first 5-day study period will be eligible for the second phase of the study. Phase 2 of the study: Patients in the second phase will receive a second cycle of the same chemotherapy. The antiemetic regimen for the
Interventions
- DRUG Cesamet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2006-08 |
| Est. Completion | 2007-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00418678
The ClinicalTrials.gov registry entry for NCT00418678 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Veeda Oncology, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Cesamet is the first listed.
NCT00418678 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00418678 about?
NCT00418678 is a clinical study titled "A Phase IV Trial of Cesamet™ Given With Standard Antiemetic Therapy for Chemotherapy-induced Nausea and Vomiting". This is a Phase IV, open-label, sequential treatment study in patients who are receiving standard chemotherapy for non-small cell lung cancer, breast cancer, or colorectal cancer. (See Section 4.2.1 for eligible treatment regimens.) The study will take place during the first 2 cycles of chemotherapy...
What is the current status of trial NCT00418678?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 16 participants. The study started on 2006-08. Estimated completion is 2007-12.
What interventions are being tested in trial NCT00418678?
The interventions under investigation include: Cesamet (DRUG).
Who is sponsoring clinical trial NCT00418678?
This trial is sponsored by Veeda Oncology, which has 9 total clinical trials registered on ClinicalTrials.gov.
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