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:
Information provided by (Responsible Party):
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT00168116
First received: September 12, 2005
Last updated: October 5, 2011
Last verified: October 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00168116

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

No publications provided

Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT00168116     History of Changes
Other Study ID Numbers: 16620
Study First Received: September 12, 2005
Last Updated: October 5, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by AHS Cancer Control Alberta:
nasopharynx
xerostomia
prevention

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

ClinicalTrials.gov processed this record on October 22, 2014