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OpenTrials
Completed

NCT Number: NCT00168116

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.

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Mouth Diseases Neoplasms Neoplasms by Site Salivary Gland Diseases Stomatognathic Diseases Xerostomia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

radiation treatment and surgery

Procedure

radiation alone

Procedure

Primary outcomes

  1. Quality of life

Secondary outcomes

  1. Treatment interruptions

  2. Incidence of percutaneous endoscopic gastronomy (PEG)

  3. Incidence of oral candidiasis

  4. Overall survival

  5. Disease free survival

  6. Pattern of recurrence

  7. Complications

Sponsors and collaborators

Lead sponsor

AHS Cancer Control Alberta

Other

Collaborators

  • Cross Cancer Institute

Registry information

Official study 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

Important dates

Study start
2000
Primary completion
2009
Study completion
2009
First posted
Sep 15, 2005
Registry last updated
Feb 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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