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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2008-04-30

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.

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Detailed Description

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Conditions

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Cancer Head and Neck Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Submandibular gland Transfer

Intervention Type PROCEDURE

Salagen

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No