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NCT00372320 · ClinicalTrials.gov registry record · Phase 1
Effect of AdhAQP1 on Salivary Flow in Patients Treated With Radiation for Head and Neck Cancer
A Phase 1 study of Parotid Salivary Dysfunction, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
- 1
- Study location
NCT00372320 is a Phase 1 study of Parotid Salivary Dysfunction that has completed, run by National Institute of Dental and Craniofacial Research (NIDCR). The registered enrollment target is 17 participants. The trial reports 1 study location across 1 state.
The verdict
NCT00372320, a Phase 1 study of Parotid Salivary Dysfunction, has completed, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will examine whether the experimental drug AdhAQP1 can increase salivary flow in patients whose parotid glands have been exposed to therapeutic radiation for treatment of head and neck cancer. Radiation may damage the parotid glands (salivary glands located under the skin in front of the ear), leading to dry mouth, infections, excessive tooth decay, mouth sores, difficulty swallowing and pain. AdhAQP1 contains the human aquaporin-1 gene, which codes for a protein that works to transport water across cells, and a virus that normally can cause colds in humans, but is modified to render it ineffective. In animal experiments, AdhAQP1 has increased saliva production for a short time. Patients between 18 years of age or older who received radiation treatment for head and neck cancer at least 5 years before enrolling in this study, who have no evidence of recurrent tumor, who have dry mouth and who secrete abnormally low levels of saliva from the parotid glands may be eligible for this study. Candidates are screened with a medical history, physical examination, blood, urine and saliva tests, electrocardiogram (EKG), chest x-ray, MRI exam, gallium scan (a nuclear medicine test to look for inflammation in the salivary glands), technetium pertechnetate scan (a nuclear medicine test to examine salivary gland function), parotid sialogram (x-ray of parotid gland), PET and CT scans to look for signs of tumor and a skin biopsy to collect skin cells for use in immunological tests. Participants have a salt and sugar solution infused through a catheter (plastic tube) into both parotid glands. After 10 minutes, the solution drains into the mouth and is swallowed. Saliva is collected from the parotid glands at 6 and 24 hours after administration of the salt and sugar solution. Ten to 14 days later, patients are admitted to the NIH Clinical Center for up to 4 days for the following tests and procedures: * On the first day, administration, through a catheter, of the study d
Conditions Studied
Interventions
- GENETIC Gene Transfer
- DRUG AdhAQP1
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2006-09-01 |
| Est. Completion | 2018-09-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00372320
The ClinicalTrials.gov registry entry for NCT00372320 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Parotid Salivary Dysfunction appearing as the primary indexed condition, and to 2 interventions - of which Gene Transfer is the first listed.
NCT00372320 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00372320 about?
NCT00372320 is a clinical study titled "Effect of AdhAQP1 on Salivary Flow in Patients Treated With Radiation for Head and Neck Cancer". This study will examine whether the experimental drug AdhAQP1 can increase salivary flow in patients whose parotid glands have been exposed to therapeutic radiation for treatment of head and neck cancer. Radiation may damage the parotid glands (salivary glands located under the skin in front of the ...
What is the current status of trial NCT00372320?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2006-09-01. Estimated completion is 2018-09-05.
What conditions does trial NCT00372320 study?
This clinical trial studies the following conditions: Parotid Salivary Dysfunction.
What interventions are being tested in trial NCT00372320?
The interventions under investigation include: Gene Transfer (GENETIC), AdhAQP1 (DRUG).
Who is sponsoring clinical trial NCT00372320?
This trial is sponsored by National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00372320 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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