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

This study has been completed.

First Received on September 9, 2005. Last Updated on April 15, 2011 History of Changes

Sponsor:	Alberta Health Services
Collaborators:	CancerCare Manitoba Jewish General Hospital Newfoundland Cancer Treatment & Research Foundation Notre-dame Hospital Ottawa Hospital Research Institute
Information provided by:	Alberta Health Services
ClinicalTrials.gov Identifier:	NCT00168181

Purpose

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	Intervention	Phase
Cancer Head and Neck Cancer	Procedure: Submandibular gland Transfer Drug: Salagen	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Dry Mouth Head and Neck Cancer

Drug Information available for: Pilocarpine hydrochloride Pilocarpine

U.S. FDA Resources

Further study details as provided by Alberta Health Services:

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

Estimated Enrollment:	220
Study Start Date:	April 2002
Estimated Study Completion Date:	April 2008

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00168181

Locations

Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2

Sponsors and Collaborators

Alberta Health Services

CancerCare Manitoba

Jewish General Hospital

Newfoundland Cancer Treatment & Research Foundation

Notre-dame Hospital

Ottawa Hospital Research Institute

Investigators

Principal Investigator:

Naresh Jha, MBBS

Alberta Health Services

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00168181 History of Changes
Other Study ID Numbers:	HN-04-0010
Study First Received:	September 9, 2005
Last Updated:	April 15, 2011
Health Authority:	Canada: Ethics Review Committee

Keywords provided by Alberta Health Services:

salagen
gland transfer
randomized
xerostomia

Additional relevant MeSH terms:

Head and Neck Neoplasms
Xerostomia
Neoplasms by Site
Neoplasms
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Pilocarpine
Miotics

Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2012