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Flexible Fiber-based CO2 Laser Versus Monopolar Cautery for Resection of Benign, Pre-malignant And Malignant Oral Cavity Lesions: A Single Center Randomized Controlled Trial Assessing Pain and Quality of Life Following Surgery


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

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Trial Information

Flexible Fiber-based CO2 Laser Versus Monopolar Cautery for Resection of Benign, Pre-malignant And Malignant Oral Cavity Lesions: A Single Center Randomized Controlled Trial Assessing Pain and Quality of Life Following Surgery


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

To demonstrate that for treatment of oral benign, oral leukoplakia and superficial T1N0M0 oral cavity lesions, CO2-fiber based resection generates less thermal damage compared to monopolar cautery

Outcome Description:

Leading to improved patient quality of life and post-operative recovery as manifested by reduced post-operative pain. Post operative pain will be measured pre-operatively, and post-operatively on post-operative day (POD) 1, 3, 7, 14, 21 and 28 using a numerical pain rating scale.

Outcome Time Frame:

1 month

Safety Issue:

No

Principal Investigator

Ian Ganly, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

11-034

NCT ID:

NCT01355926

Start Date:

May 2011

Completion Date:

May 2014

Related Keywords:

  • Head and Neck Cancer
  • Flexible Fiber-based CO2 Laser
  • Monopolar Cautery
  • Oral Cavity Lesions
  • Quality of life
  • Assessing Pain
  • 11-034
  • Head and Neck Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021