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Sponsors and Collaborators: |
Alberta Cancer Board CancerCare Manitoba Jewish General Hospital Newfoundland Cancer Treatment & Research Foundation Notre-dame Hospital Ottawa Health Research Institute |
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Information provided by: | Alberta Cancer Board |
ClinicalTrials.gov Identifier: | NCT00168181 |
This is a study to see whether the drug Salagen or salivary gland transfer is better for the prevention of dryness of the mouth in patients with head and neck cancer receiving radiation treatment.
Condition | Intervention | Phase |
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Cancer Head and Neck Cancer |
Procedure: Submandibular gland Transfer Drug: Salagen |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III Randomized Trial Comparing Oral Pilocarpine (Salagen) Versus Submandibular Salivary Gland Transfer Protocol, For the Prevention of Radiation (XRT) Induced Xerostomia in Head and Neck Cancer Patients |
Estimated Enrollment: | 220 |
Study Start Date: | April 2002 |
Estimated Study Completion Date: | April 2008 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Naresh Jha, MBBS | (780) 432-8755 | nareshj@cancerboard.ad.ca |
Canada, Alberta | |
Cross Cancer Institute | Recruiting |
Edmonton, Alberta, Canada, T6G 1Z2 | |
Contact: Naresh Jha, MBBS (780) 432-8755 | |
Contact: Clinical Research Unit 780-989-8152 clinical_trials_cci@cancerboard.ab.ca | |
Principal Investigator: Naresh Jha, MBBS |
Principal Investigator: | Naresh Jha, MBBS | Alberta Cancer Board |
Study ID Numbers: | HN-04-0010 |
Study First Received: | September 9, 2005 |
Last Updated: | September 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00168181 |
Health Authority: | Canada: Ethics Review Committee |
salagen gland transfer randomized xerostomia |
Mouth Diseases Head and Neck Neoplasms Pilocarpine |
Stomatognathic Diseases Salivary Gland Diseases Xerostomia |
Neurotransmitter Agents Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Cholinergic Agonists Autonomic Agents |
Miotics Physiological Effects of Drugs Muscarinic Agonists Peripheral Nervous System Agents Cholinergic Agents Pharmacologic Actions |