Status:
COMPLETED
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
Lead Sponsor:
Alberta Health services
Collaborating Sponsors:
CancerCare Manitoba
Jewish General Hospital
Conditions:
Cancer
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Recurrent disease
- Allergy to pilocarpine
- Patients with uncontrolled asthma, acute iritis, or narrow angle glaucoma
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2008
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT00168181
Start Date
April 1 2002
End Date
April 1 2008
Last Update
April 18 2011
Active Locations (1)
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1
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2