Side Effects of High-Dose Intensity-Modulated Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer

Completed

• Conditions: Long-term Effects Secondary to Cancer Therapy in Adults; Oral Complications of Radiation Therapy; Head and Neck Cancer; Radiation Toxicity

• Registration Number: NCT00415025
• Lead Sponsor: University of Wisconsin, Madison

Brief Summary

RATIONALE: Tests that measure how much saliva is made, hearing, swallowing, voice function, and quality of life may improve the ability to plan treatment for patients with advanced head and neck cancer and may help doctors find better ways to treat the cancer.

PURPOSE: This clinical trial is studying the side effects of high-dose intensity-modulated radiation therapy in treating patients with advanced head and neck cancer.

Detailed Description

OBJECTIVES:

Primary

* Assess salivary function in patients with advanced head and neck cancer treated with intensity-modulated radiotherapy (IMRT) by measuring stimulated saliva production at 6 and 12 months after completion of therapy.

* Compare salivary function in these patients to salivary function in historical controls.

Secondary

* Assess auditory, swallow, and voice function and quality of life of these patients before and after IMRT or chemoradiotherapy.

* Advance experience with IMRT/tomotherapy and improve field design for irradiating head and neck cancer in an effort to reduce radiation dose and minimize effects on surrounding normal tissue.

OUTLINE: This is a prospective study.

Patients undergo standard of care high-dose intensity-modulated radiotherapy (IMRT) to the head and neck.

Patients undergo baseline and post-treatment testing of auditory, salivary, swallow, and voice function as well as quality of life evaluation.

Patients are evaluated for radiation-induced toxicities at 1, 6, and 12 months after completion of IMRT.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2006-12-21
• Study First Submitted QC: 2006-12-21
• Study First Posted: 2006-12-22
• Study Completion: 2007-07
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-15
• Last Update Posted: 2015-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of salivary function of patients in current study to salivary function of historical controls
Stimulated saliva production at 6 months after completion of intensity-modulated radiotherapy (IMRT)

Secondary Outcome Measures

Name	Time	Method
Auditory, swallow, and voice function at 6 months after completion of IMRT
Toxicities as measured by NCI CTCAE v3.0
Quality of Life (QOL) as assessed at baseline and at 1, 6, and 12 months after completion of IMRT
Improvement in IMRT/tomotherapy field design