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
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ClinicalTrials.gov Identifier: NCT00168181
Recruitment Status :
First Posted : September 15, 2005
Last Update Posted : April 18, 2011
Alberta Health Services
Jewish General Hospital
Newfoundland Cancer Treatment & Research Foundation
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
Study Start Date :
Study Completion Date :
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To compare the efficacy of prevention of XRT induced xerostomia using two different approaches: oral Pilocarpine versus submandibular salivary gland transfer protocol; To compare the rate and severity of XRT induced xerostomia using these two strategies
Secondary Outcome Measures :
To evaluate the incidence of oral candidiasis, percutaneous endoscopic gastrostomy (PEG), and hospitalization during XRT
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Previously untreated and confirmed histological diagnosis of squamous cell/adenoid cystic carcinoma of the oropharynx, hypopharynx, larynx, and patients with unknown primary tumor with metastases to the neck nodes and squamous cell carcinoma of the skin of head and neck region with ipsilateral neck nodes (more than one node) metastases.
Radiation volume to encompass > or equal to 80% of major salivary glands (parotids and the non-transferred submandibular salivary gland) and have > or equal to 50 Gys delivered to that volume via external beam.
Karnofsky performance score > or equal to 70
Minimum age 18 years
The patient must sign a study-specific informed consent prior to study entry
Expected survival > or equal to one year
Carcinoma of nasopharynx, oral cavity, N3 disease, bilateral neck node involvement, pre-epiglottic space involvement, involvement of level 1 nodes on either side of the neck, and patients with post-operative recurrent disease.
Salivary gland malignancy
Salivary gland disease
Use of anti-cholinergic drugs and tricyclic drugs
Delay in XRT of more than 8 weeks following the curative surgery
Pregnant or lactating females are not eligible. Patients of childbearing potential should agree to use an effective method of contraception
Prior head and neck irradiation
Allergy to pilocarpine
Patients with uncontrolled asthma, acute iritis, or narrow angle glaucoma