- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00168116
Xerostomia in Head and Neck Cancer Patients Receiving Radiation as the Primary Treatment Versus Patients Who Will Not Have Such a Procedure
February 23, 2016 updated by: AHS Cancer Control Alberta
To Evaluate the Effects of Transfer of Submandibular Salivary Gland to the Submental Region (Outside the Radiation Field) on Xerostomia in Head and Neck Cancer Patients Receiving Radiation as the Primary Treatment Versus Patients Who Will Not Have Such a Procedure
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Alberta
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Edmonton, Alberta, Canada, T6G 1Z2
- Cross Cancer Institute
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Exclusion Criteria:
- Bilateral neck nodes involvement. Involvement of level 1 lymph nodes on the side of the proposed procedure.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Quality of life
|
Secondary Outcome Measures
Outcome Measure |
---|
Overall survival
|
Disease free survival
|
Complications
|
Treatment interruptions
|
Incidence of percutaneous endoscopic gastronomy (PEG)
|
Incidence of oral candidiasis
|
Pattern of recurrence
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Naresh Jha, MBBA, AHS Cancer Control Alberta
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2000
Primary Completion (Actual)
May 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 15, 2005
Study Record Updates
Last Update Posted (Estimate)
February 24, 2016
Last Update Submitted That Met QC Criteria
February 23, 2016
Last Verified
October 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16620
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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