Side Effects of High-Dose Intensity-Modulated Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT00415025|
Recruitment Status : Completed
First Posted : December 22, 2006
Last Update Posted : October 16, 2015
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.
|Condition or disease||Intervention/treatment|
|Head and Neck Cancer Long-term Effects Secondary to Cancer Therapy in Adults Oral Complications of Radiation Therapy Radiation Toxicity||Procedure: adjuvant therapy Procedure: management of therapy complications Procedure: quality-of-life assessment Radiation: intensity-modulated radiation therapy|
- 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.
- 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|
|Estimated Enrollment :||20 participants|
|Official Title:||Evaluation of Normal Tissue Toxicities in Head and Neck Cancer Patients Receiving Intensity Modulated Radiotherapy (IMRT)|
|Study Start Date :||June 2004|
|Actual Study Completion Date :||July 2007|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00415025
|Study Chair:||Paul M. Harari, MD||University of Wisconsin, Madison|