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

University of Wisconsin, Madison20 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Head and Neck Cancer Long-term Effects Secondary to Cancer Therapy in Adults

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Histologically confirmed advanced head and neck cancer * Indication for radiotherapy or chemoradiotherapy as primary or postoperative therapy AND meets 1 of the following criteria: * More than 75% of bilateral parotid glands expected to receive ≥ 45 cGy of radiation using conventional treatment field design * Either or both central auditory apparatus predicted to receive \> 45 cGy of radiation PATIENT CHARACTERISTICS: * No comorbid medical condition that would preclude radiotherapy * No serious concurrent psychosocial, familial, sociological, geographical, or other condition that would preclude study compliance PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Outcomes

Primary Outcomes

Stimulated saliva production at 6 months after completion of intensity-modulated radiotherapy (IMRT)

Comparison of salivary function of patients in current study to salivary function of historical controls

Secondary Outcomes

Auditory, swallow, and voice function at 6 months after completion of IMRT

Quality of Life (QOL) as assessed at baseline and at 1, 6, and 12 months after completion of IMRT

Toxicities as measured by NCI CTCAE v3.0

Improvement in IMRT/tomotherapy field design