Trial Information
To Evaluate the Effects of Transfer of Submandibular Salivary Gland to the Submental Region (Outside the Radiation Field) on Xerostomia in Head and Neck Cancer Patients Receiving Radiation as the Primary Treatment Versus Patients Who Will Not Have Such a Procedure
Inclusion Criteria:
- Patients with a histological diagnosis of squamous cell carcinoma
- Patients with unilateral or no neck involvement of the nasopharynx
- The submandibular transfer will be done on the uninvolved side of the neck.
- Karnofsky score greater than or equal to 70
- Expected survival greater than one year
- A signed informed consent
Exclusion Criteria:
- Bilateral neck nodes involvement. Involvement of level 1 lymph nodes on the side of
the proposed procedure.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Quality of life
Principal Investigator
Naresh Jha, MBBA
Investigator Role:
Principal Investigator
Investigator Affiliation:
Alberta Health Services
Authority:
Canada: Ethics Review Committee
Study ID:
16620
NCT ID:
NCT00168116
Start Date:
July 2000
Completion Date:
June 2009
Related Keywords:
- Head and Neck Cancer
- nasopharynx
- xerostomia
- prevention
- Head and Neck Neoplasms
- Xerostomia