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

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. Identifier: NCT00497406
Recruitment Status : Unknown
Verified March 2016 by AHS Cancer Control Alberta.
Recruitment status was:  Active, not recruiting
First Posted : July 6, 2007
Last Update Posted : March 16, 2016
Cross Cancer Institute
Information provided by (Responsible Party):
AHS Cancer Control Alberta

Brief Summary:
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 or disease Intervention/treatment
Head and Neck Cancer Procedure: Salivary gland transfer Procedure: Helical Tomotherapy treatment

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2005
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Procedure: Salivary gland transfer
    Retrograde flow method
    Procedure: Helical Tomotherapy treatment
    total of 30 fractions

Primary Outcome Measures :
  1. reduction of Xerostomia after surgery [ Time Frame: 2-3 weeks after surgery, 6 months and 12 months ]
    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

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

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

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 identifier (NCT number): NCT00497406

Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
AHS Cancer Control Alberta
Cross Cancer Institute
Study Chair: Rufus Scrimger, MD, FRCPC AHS Cancer Control Alberta

Responsible Party: AHS Cancer Control Alberta Identifier: NCT00497406     History of Changes
Other Study ID Numbers: HN-4-0027/ethics 22128
First Posted: July 6, 2007    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: March 2016

Keywords provided by AHS Cancer Control Alberta:
submandibular salivary gland transfer
intensity-modulated radiation therapy
helical tomotherapy
reduction of xerostomia

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