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

NCT00168181 | Completed Phase 3

• 1 other identifier: HN-04-0010
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Head and Neck Cancer

Keywords

salagen; gland transfer; randomized; xerostomia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To evaluate the incidence of oral candidiasis, percutaneous endoscopic gastrostomy (PEG), and hospitalization during XRT

Interventions

Submandibular gland Transfer PROCEDURE

Salagen DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alberta Health services: lead
• CancerCare Manitoba: collaborator
• Jewish General Hospital: collaborator
• Newfoundland Cancer Treatment & Research Foundation: collaborator
• Notre-dame Hospital: collaborator
• Ottawa Hospital Research Institute: collaborator

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

MeSH Terms

Conditions

Neoplasms; Head and Neck Neoplasms; Xerostomia

Interventions

Pilocarpine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• Naresh Jha, MBBS

  AHS Cancer Control Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 15, 2005
• Study Start: April 1, 2002
• Study Completion: April 1, 2008
• Last Updated: April 18, 2011

Record last verified: 2011-04

Locations

CA (1)