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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00168181
• Other study ID #: HN-04-0010
• Status: Completed
• Phase: Phase 3
• First received: September 9, 2005
• Last updated: April 15, 2011
• Start date: April 2002
• Est. completion date: April 2008

Study information

• Verified date: April 2011
• Source: AHS Cancer Control Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cancer
• Head and Neck Cancer
• Head and Neck Neoplasms
• Xerostomia

Intervention

Procedure:
• Submandibular gland Transfer

Drug:
• Salagen

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta

Sponsors (6)

Lead Sponsor	Collaborator
Alberta Health Services	CancerCare Manitoba, Jewish General Hospital, Newfoundland Cancer Treatment & Research Foundation, Notre-dame Hospital, Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To evaluate the incidence of oral candidiasis, percutaneous endoscopic gastrostomy (PEG), and hospitalization during XRT