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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 ongoing, but not recruiting participants.
Cross Cancer Institute
Information provided by (Responsible Party):
AHS Cancer Control Alberta Identifier:
First received: July 3, 2007
Last updated: March 14, 2016
Last verified: March 2016
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: 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

Resource links provided by NLM:

Further study details as provided by AHS Cancer Control Alberta:

Primary Outcome Measures:
  • 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

Enrollment: 46
Study Start Date: December 2005
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (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


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
  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 identifier: 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
  More Information

Responsible Party: AHS Cancer Control Alberta Identifier: NCT00497406     History of Changes
Other Study ID Numbers: HN-4-0027/ethics 22128
Study First Received: July 3, 2007
Last Updated: March 14, 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 processed this record on August 18, 2017