Clinical trial NCT00168181: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cancer
Head and Neck Cancer
Keywords: salagen
gland transfer
randomized
xerostomia
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
Collaborators: name: CancerCare Manitoba
name: Jewish General Hospital
name: Newfoundland Cancer Treatment & Research Foundation
name: Notre-dame Hospital
name: Ottawa Hospital Research Institute
First posted: 2005-09-15
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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:
measure: To evaluate the incidence of oral candidiasis, percutaneous endoscopic gastrostomy (PEG), and hospitalization during XRT
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: AHS Cancer Control Alberta
name: Naresh Jha, MBBS
role: PRINCIPAL_INVESTIGATOR
References: