NCT Number: NCT00415025
Side Effects of High-Dose Intensity-Modulated Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer
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.
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Conditions
Age range
18 year–120 year
Sex eligibility
All sexes
Study type
Observational
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
management of therapy complications
Procedurequality-of-life assessment
ProcedureIntensity-Modulated Radiation Therapy
RadiationPrimary 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
Sponsors and collaborators
Lead sponsor
University of Wisconsin, Madison
Other
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study title
Evaluation of Normal Tissue Toxicities in Head and Neck Cancer Patients Receiving Intensity Modulated Radiotherapy (IMRT)
Important dates
- Study start
- 2004
- Study completion
- 2007
- First posted
- Dec 22, 2006
- Registry last updated
- Oct 16, 2015
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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