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
Information source: Alberta Cancer Board
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cancer; Head and Neck Cancer
Intervention: Submandibular gland Transfer (Procedure); Salagen (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Alberta Cancer Board Official(s) and/or principal investigator(s):
Naresh Jha, MBBS, Principal Investigator, Affiliation: Alberta Cancer Board
Overall contact:
Naresh Jha, MBBS, Phone: (780) 432-8755, Email: nareshj@cancerboard.ad.ca
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.
Clinical Details
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 design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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: To evaluate the incidence of oral candidiasis, percutaneous endoscopic gastrostomy (PEG), and hospitalization during XRT
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Naresh Jha, MBBS, Phone: (780) 432-8755, Email: nareshj@cancerboard.ad.ca
Cross Cancer Institute, Edmonton, Alberta T6G 1Z2, Canada; Recruiting
Naresh Jha, MBBS, Phone: (780) 432-8755
Clinical Research Unit, Phone: 780-989-8152, Email: clinical_trials_cci@cancerboard.ab.ca
Naresh Jha, MBBS, Principal Investigator
Additional Information
Starting date: April 2002
Ending date: April 2008
Last updated: September 22, 2008
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