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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00168116
First Posted: September 15, 2005
Last Update Posted: February 24, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Cross Cancer Institute
Information provided by (Responsible Party):
AHS Cancer Control Alberta
  Purpose
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.

Condition Intervention Phase
Head and Neck Cancer Procedure: radiation treatment and surgery Procedure: radiation alone Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AHS Cancer Control Alberta:

Primary Outcome Measures:
  • Quality of life

Secondary Outcome Measures:
  • Treatment interruptions
  • Incidence of percutaneous endoscopic gastronomy (PEG)
  • Incidence of oral candidiasis
  • Overall survival
  • Disease free survival
  • Pattern of recurrence
  • Complications

Enrollment: 42
Study Start Date: July 2000
Study Completion Date: June 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

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): NCT00168116


Locations
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
AHS Cancer Control Alberta
Cross Cancer Institute
Investigators
Principal Investigator: Naresh Jha, MBBA AHS Cancer Control Alberta
  More Information

Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT00168116     History of Changes
Other Study ID Numbers: 16620
First Submitted: September 12, 2005
First Posted: September 15, 2005
Last Update Posted: February 24, 2016
Last Verified: October 2011

Keywords provided by AHS Cancer Control Alberta:
nasopharynx
xerostomia
prevention

Additional relevant MeSH terms:
Head and Neck Neoplasms
Xerostomia
Neoplasms by Site
Neoplasms
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases