A Single Center Randomized Controlled Trial Assessing Pain and Quality of Life Following Surgery

Completed · Not applicable

Conditions studied: Head and Neck Cancer

In brief

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.

Key facts

Study ID

NCT01355926

Run by

Memorial Sloan Kettering Cancer Center

People needed

68

Starts

2011-05-01

Expected to finish

2021-01-13

Last updated by the study team

2021-01-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Patients with previous Head and Neck radiation
• Pregnant or lactating female patients.
• Patients with oral cavity squamous cell cancer requiring neck dissection

Where it is running

• Memoral Sloan Kettering Cancer Center — Basking Ridge, New Jersey, United States
• Memoral Sloan Kettering Monmouth — Middletown, New Jersey, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Memorial Sloan Kettering Rockville Centre — Rockville Centre, New York, United States

Full record on ClinicalTrials.gov

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