A Single Center Randomized Controlled Trial Assessing Pain and Quality of Life Following Surgery
Conditions
Head and Neck Cancer
Conditions: official terms
Head and Neck Neoplasms
Conditions: Keywords
Flexible Fiber-based CO2 Laser, Monopolar Cautery, Oral Cavity Lesions, Quality of life, Assessing Pain, 11-034
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Intervention
Name: Flexible Fiber-based CO2 Laser, Quality of Life forms Type: Other
Name: electrocautery resection and quality of life forms Type: Other
Overall Status
Recruiting
Summary
The purpose of this study is to help us to better understand the effects of two different types of surgical techniques on pain and quality of life in patients with precancerous lesions or early stage mouth cancers.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Biopsy proven diagnosis or clinical diagnosis of any benign oral cavity lesion. Pre-surgical biopsy will not be required if lesion is suspected to be benign.

- Biopsy proven diagnosis or clinical diagnosis of premalignant oral cavity lesions (leukoplakia, erythroplakia, lichen planus, dysplasia)Pre-surgical biopsy will not be required if lesion is suspected to be benign.

- Biopsy proven diagnosis of small superficial oral cavity SCC (stage T1N0) requiring resection without the need for neck dissection.

- All pathology will be reviewed at MSK to confirm diagnosis.

- The lesion plus the resection margin should not exceed 4.0 cm circumferentially.

- Planned to undergo surgical treatment by resection without flap reconstruction and without neck dissection.

- All patients age 18 years of age and older.

- Karnofsky performance score over 60.

Patients on blood thinners (aspirin or Coumadin) will be asked to stop medications 7 days prior to surgery. In the case of Coumadin, patients are switched to lovenox 7 days prior to surgery and this is stopped the day before surgery. Following surgery aspirin or Coumadin are recommenced 48 hours postop.

Exclusion Criteria:

- Patients with previous Head and Neck radiation

- Pregnant or lactating female patients.

- Patients with oral cavity squamous cell cancer requiring neck dissection
Location
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Status: Recruiting
Contact: Ian Ganly, MD - 212-639-6244
Start Date
May 2011
Completion Date
May 2016
Sponsors
Memorial Sloan Kettering Cancer Center
Source
Memorial Sloan Kettering Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page