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

Sponsor

Alberta Health services (Other)

Overall Status

Completed

CT.gov ID

NCT00168181

Collaborator

CancerCare Manitoba (Other), Jewish General Hospital (Other), Newfoundland Cancer Treatment & Research Foundation (Other), Notre-dame Hospital (Other), Ottawa Hospital Research Institute (Other)

220

Enrollment

Location

Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer Head and Neck Cancer	Procedure: Submandibular gland Transfer Drug: Salagen	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

220 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Study Start Date :

Apr 1, 2002

Study Completion Date :

Apr 1, 2008

Outcome Measures

Primary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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