Xerostomia in Head and Neck Cancer Patients Receiving Radiation as the Primary Treatment Versus Patients Who Will Not Have Such a Procedure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-07-31

Study Completion Date

2009-06-30

Brief Summary

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The purpose of this study is to compare the side effects of radiation treatment and surgery versus radiation alone, where no surgery is done to move the salivary gland and place it under the chin region where it can be shielded from radiation.

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Detailed Description

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Conditions

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Head and Neck Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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radiation treatment and surgery

Intervention Type PROCEDURE

radiation alone

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with a histological diagnosis of squamous cell carcinoma
* Patients with unilateral or no neck involvement of the nasopharynx
* The submandibular transfer will be done on the uninvolved side of the neck.
* Karnofsky score greater than or equal to 70
* Expected survival greater than one year
* A signed informed consent