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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
September 12, 2005
September 15, 2005
February 24, 2016
July 2000
May 2009   (Final data collection date for primary outcome measure)
Quality of life
Same as current
Complete list of historical versions of study NCT00168116 on ClinicalTrials.gov Archive Site
  • Treatment interruptions
  • Incidence of percutaneous endoscopic gastronomy (PEG)
  • Incidence of oral candidiasis
  • Overall survival
  • Disease free survival
  • Pattern of recurrence
  • Complications
  • Treatment interruptions
  • Incidence of PEG
  • Incidence of oral candidaasis
  • Overall survival
  • Disease free survival
  • Pattern of recurrence
  • Complications
Not Provided
Not Provided
 
Xerostomia in Head and Neck Cancer Patients Receiving Radiation as the Primary Treatment Versus Patients Who Will Not Have Such a Procedure
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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Head and Neck Cancer
  • Procedure: radiation treatment and surgery
  • Procedure: radiation alone
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
June 2009
May 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00168116
16620
Yes
Not Provided
Not Provided
AHS Cancer Control Alberta
AHS Cancer Control Alberta
Cross Cancer Institute
Principal Investigator: Naresh Jha, MBBA AHS Cancer Control Alberta
AHS Cancer Control Alberta
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP