search
Back to results

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

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
radiation treatment and surgery
radiation alone
Sponsored by
AHS Cancer Control Alberta
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Head and Neck Cancer focused on measuring nasopharynx, xerostomia, prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cross Cancer Institute

Outcomes

Primary Outcome Measures

Quality of life

Secondary Outcome Measures

Treatment interruptions
Incidence of percutaneous endoscopic gastronomy (PEG)
Incidence of oral candidiasis
Overall survival
Disease free survival
Pattern of recurrence
Complications

Full Information

First Posted
September 12, 2005
Last Updated
February 23, 2016
Sponsor
AHS Cancer Control Alberta
Collaborators
Cross Cancer Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT00168116
Brief Title
Xerostomia in Head and Neck Cancer Patients Receiving Radiation as the Primary Treatment Versus Patients Who Will Not Have Such a Procedure
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
July 2000 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AHS Cancer Control Alberta
Collaborators
Cross Cancer Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
nasopharynx, xerostomia, prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
radiation treatment and surgery
Intervention Type
Procedure
Intervention Name(s)
radiation alone
Primary Outcome Measure Information:
Title
Quality of life
Secondary Outcome Measure Information:
Title
Treatment interruptions
Title
Incidence of percutaneous endoscopic gastronomy (PEG)
Title
Incidence of oral candidiasis
Title
Overall survival
Title
Disease free survival
Title
Pattern of recurrence
Title
Complications

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naresh Jha, MBBA
Organizational Affiliation
AHS Cancer Control Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs