Trials / Completed
CompletedNCT00415025
Side Effects of High-Dose Intensity-Modulated Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer
Evaluation of Normal Tissue Toxicities in Head and Neck Cancer Patients Receiving Intensity Modulated Radiotherapy (IMRT)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 20 (estimated)
- Sponsor
- University of Wisconsin, Madison · Academic / Other
- Sex
- All
- Age
- 18 Years – 120 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Head and Neck Cancer
- Long-term Effects Secondary to Cancer Therapy in Adults
- Oral Complications of Radiation Therapy
- Radiation Toxicity
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | adjuvant therapy | |
| PROCEDURE | management of therapy complications | |
| PROCEDURE | quality-of-life assessment | |
| RADIATION | intensity-modulated radiation therapy |
Timeline
- Start date
- 2004-06-01
- Completion
- 2007-07-01
- First posted
- 2006-12-22
- Last updated
- 2015-10-16
Source: ClinicalTrials.gov record NCT00415025. Inclusion in this directory is not an endorsement.