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NCT00503776 · ClinicalTrials.gov registry record · Phase 2
Chemo/XRT +/- Amifostine to Assess Outcomes Related to Xerostomia, Mucositis, & Dysphagia
A Phase 2 study, sponsored by Vanderbilt-Ingram Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 41
- Enrollment target
NCT00503776 is a Phase 2 study that was terminated before completion, run by Vanderbilt-Ingram Cancer Center. The registered enrollment target is 41 participants.
The verdict
NCT00503776, a Phase 2 study, was terminated before completion, sponsored by Vanderbilt-Ingram Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 41 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Amifostine may decrease the side effects caused by chemotherapy and radiation therapy. It is not yet known whether chemotherapy and radiation therapy are more effective with or without amifostine in treating head and neck cancer. PURPOSE: This randomized phase II trial is studying amifostine to see how well it works compared with standard care in reducing side effects in patients undergoing chemotherapy and radiation therapy for stage III or stage IV head and neck cancer.
Interventions
- BEHAVIORAL exercise intervention
- DRUG amifostine trihydrate
- PROCEDURE therapeutic dietary intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2006-01 |
| Est. Completion | 2008-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00503776
The ClinicalTrials.gov registry entry for NCT00503776 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt-Ingram Cancer Center, which has 189 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which exercise intervention is the first listed.
NCT00503776 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00503776 about?
NCT00503776 is a clinical study titled "Chemo/XRT +/- Amifostine to Assess Outcomes Related to Xerostomia, Mucositis, & Dysphagia". RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Amifostine may decrease the side effects caused by chemotherapy and radiation ...
What is the current status of trial NCT00503776?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 41 participants. The study started on 2006-01. Estimated completion is 2008-08.
What interventions are being tested in trial NCT00503776?
The interventions under investigation include: exercise intervention (BEHAVIORAL), amifostine trihydrate (DRUG), therapeutic dietary intervention (PROCEDURE).
Who is sponsoring clinical trial NCT00503776?
This trial is sponsored by Vanderbilt-Ingram Cancer Center, which has 189 total clinical trials registered on ClinicalTrials.gov.
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