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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

Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIISupportive careCompleted18 and overOtherHN-04-0010
NCT00168181

Trial Description

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 Criteria:

1. 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.

2. 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.

3. Karnofsky performance score > or equal to 70

4. Minimum age 18 years

5. The patient must sign a study-specific informed consent prior to study entry

6. Expected survival > or equal to one year

Exclusion Criteria:

1. 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.

2. Salivary gland malignancy

3. Salivary gland disease

4. Use of anti-cholinergic drugs and tricyclic drugs

5. Delay in XRT of more than 8 weeks following the curative surgery

6. Pregnant or lactating females are not eligible. Patients of childbearing potential should agree to use an effective method of contraception

7. Prior head and neck irradiation

8. Recurrent disease

9. Allergy to pilocarpine

10. Patients with uncontrolled asthma, acute iritis, or narrow angle glaucoma

Trial Contact Information

Trial Lead Organizations/Sponsors

AHS Cancer Control Alberta

CancerCare Manitoba

Jewish General Hospital - Montreal

Doctor H. Bliss Murphy Cancer Centre

Hopital Notre-Dame du CHUM

Ottawa Hospital Regional Cancer Centre - General Campus

Naresh Jha, MBBSPrincipal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00168181
ClinicalTrials.gov processed this data on October 24, 2013

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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