Xerostomia in Head and Neck Cancer Patients Receiving Radiation as the Primary Treatment Versus Patients Who Will Not Have Such a Procedure

AHS Cancer Control Alberta

Status and phase: Completed; Phase 2

Conditions: Head and Neck Cancer

Treatments: Procedure: radiation alone; Procedure: radiation treatment and surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT00168116

16620

Details and patient eligibility

About

The purpose of this study is to compare the side effects of radiation treatment and surgery versus radiation alone, where no surgery is done to move the salivary gland and place it under the chin region where it can be shielded from radiation.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)