Xerostomia in Head and Neck Cancer Patients Receiving Radiation as the Primary Treatment Versus Patients Who Will Not Have Such a Procedure
Phase 2
Completed
- Conditions
- Head and Neck Cancer
- Registration Number
- NCT00168116
- Lead Sponsor
- AHS Cancer Control Alberta
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Quality of life
- Secondary Outcome Measures
Name Time Method Complications Incidence of oral candidiasis Overall survival Disease free survival Pattern of recurrence Treatment interruptions Incidence of percutaneous endoscopic gastronomy (PEG)
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie salivary gland transfer in mitigating radiation-induced xerostomia in head and neck cancer?
How does submandibular gland relocation compare to standard-of-care interventions for xerostomia in head and neck cancer patients?
Are there specific biomarkers that predict response to submental salivary gland transfer in radiation therapy for head and neck cancer?
What are the potential adverse events and management strategies for submandibular gland transfer in head and neck cancer patients undergoing radiation therapy?
What combination approaches or alternative therapies are being explored alongside salivary gland relocation for managing xerostomia in head and neck cancer patients?
Trial Locations
- Locations (1)
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
Cross Cancer Institute🇨🇦Edmonton, Alberta, Canada