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NCT00168116 Clinical Trial

Xerostomia in Head and Neck Cancer Patients Receiving Radiation as the Primary Treatment Versus Patients Who Will Not Have Such a Procedure

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00168116
Other study ID # 16620
Secondary ID
Status Completed
Phase Phase 2
First received September 12, 2005
Last updated February 23, 2016
Start date July 2000
Est. completion date June 2009

Study information
Verified date October 2011
Source AHS Cancer Control Alberta
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 42
Est. completion date June 2009
Est. primary completion date May 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Procedure:
• radiation treatment and surgery

• radiation alone

Locations
Country Name City State
Canada Cross Cancer Institute Edmonton Alberta

Sponsors (2)
Lead Sponsor Collaborator
AHS Cancer Control Alberta Cross Cancer Institute

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Quality of life
Secondary Treatment interruptions
Secondary Incidence of percutaneous endoscopic gastronomy (PEG)
Secondary Incidence of oral candidiasis
Secondary Overall survival
Secondary Disease free survival
Secondary Pattern of recurrence
Secondary Complications
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