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A Pilot Study to Evaluate the Feasibility of Combining Submandibular Salivary Gland Tx & IMRT Tomo to Reduce Xerostomia

This study is currently recruiting participants.
Verified April 2012 by Alberta Health Services
Sponsor:
Information provided by (Responsible Party):
Alberta Health Services
ClinicalTrials.gov Identifier:
NCT00497406
First received: July 3, 2007
Last updated: April 4, 2012
Last verified: April 2012
History of Changes
  Purpose

A study for head and neck cancer patients to evaluate the feasibility of combining salivary gland transfer surgical procedure and IMRT helical tomotherapy to reduce dryness of mouth.


Condition Intervention
Head and Neck Cancer
 Procedure: Salivary gland transfer
Procedure: Helical Tomotherapy treatment

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Pilot Study to Evaluate the Feasibility of Combining Submandibular Salivary Gland Transfer Procedure and Intensity Modulated Radiation Therapy (Helical Tomotherapy) to Reduce Dryness of Mouth (Xerostomia) in Head and Neck Cancer Patients After Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alberta Health Services:

Primary Outcome Measures:
  • reduction of Xerostomia after surgery [ Time Frame: 2-3 weeks after surgery, 6 months and 12 months ] [ Designated as safety issue: Yes ]
    combining submandibular salivary gland transfer procedure and intensity modulated radiation therapy (helical tomotherapy) to reduce dryness of mouth in head and neck cancer patients after surgery


Estimated Enrollment: 12
Study Start Date: December 2005
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Salivary gland transfer
    Retrograde flow method
    Procedure: Helical Tomotherapy treatment
    total of 30 fractions
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • histologically-proven newly-diagnosed squamous cell carcinoma of oropharynx, larynx, hypopharynx and unknown primary of cancer with neck node metastasis after primary surgery
  • AJCC stage I-IV patients are eligible provided they are MO and NO-2b
  • 18 years of age or older
  • KPS of 70 or greater

Exclusion Criteria:

  • N3/N2C disease or M1 disease
  • salivary gland disease i.e. Sjogren's syndrome
  • prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for at least 5 years
  • prior radiotherapy to the head and neck region
  • lymph node involvement (level I-III) or proximity of disease to submandibular gland on the side chosen for salivary gland transfer on frozen section or permanent pathological evaluation
  • pre-epiglottic space involvement on pathological examination
  • involvement of level I nodes on either side of neck
  • post-op recurrent disease at presentation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00497406

Contacts
Contact: Elizabeth Gaetz, RN 780-577-8029 elizabeth.gaetz@alberthealthservices.ca
Contact: Michelle Encarnacao, RN 780-432-8234 michenca@cancerboard.ab.ca

Locations
Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact     780-577-8029     clinical_trials_cci@cancerboard.ab.ca    
Sub-Investigator: Naresh Jha, MD, FRCPC            
Sub-Investigator: Matthew Parliament, MD, FRCPC            
Sponsors and Collaborators
Alberta Health Services
Investigators
Study Chair: Rufus Scrimger, MD, FRCPC Alberta Health Services
  More Information

No publications provided

Responsible Party: Alberta Health Services
ClinicalTrials.gov Identifier: NCT00497406     History of Changes
Other Study ID Numbers: HN-4-0027/ethics 22128
Study First Received: July 3, 2007
Last Updated: April 4, 2012
Health Authority: Canada: Health Canada

Keywords provided by Alberta Health Services:
submandibular salivary gland transfer
intensity-modulated radiation therapy
helical tomotherapy
reduction of xerostomia

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

ClinicalTrials.gov processed this record on May 23, 2013