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Clinical Trials/NCT00415025
NCT00415025CompletedNot Applicable

Evaluation of Normal Tissue Toxicities in Head and Neck Cancer Patients Receiving Intensity Modulated Radiotherapy (IMRT)

University of Wisconsin, Madison0 sites20 target enrollmentStarted: June 2004Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Primary Endpoint
Comparison of salivary function of patients in current study to salivary function of historical controls
Study OverviewEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18 Years to 120 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

  • Auditory, swallow, and voice function at 6 months after completion of IMRT
  • Toxicities as measured by NCI CTCAE v3.0
  • Quality of Life (QOL) as assessed at baseline and at 1, 6, and 12 months after completion of IMRT
  • Improvement in IMRT/tomotherapy field design

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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