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

University of Wisconsin (UW)

Status: Completed

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

Treatments: Procedure: management of therapy complications; Procedure: quality-of-life assessment; Procedure: adjuvant therapy; Radiation: intensity-modulated radiation therapy

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00415025

CDR0000515323

WCCC-RO-03313

H-2004-0168

P30CA014520 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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