Trial | NCT00168181  Report issue

Title

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
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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    pilocarpine ...

  • Study Participants

    220
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.
Study Started
Apr 30
2002
Study Completion
Apr 30
2008
Last Update
Apr 18
2011
Estimate

Procedure Submandibular gland Transfer

Drug Salagen

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
No Results Posted