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 Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cancer, Head and Neck Cancer

Intervention / Treatment
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* Procedure: Submandibular gland Transfer
* Drug: Salagen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Submandibular gland Transfer|nan|
|Drug: Salagen|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the incidence of oral candidiasis, percutaneous endoscopic gastrostomy (PEG), and hospitalization during XRT |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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salagen, gland transfer, randomized, xerostomia