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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT01355926

Collaborator

OMNIGUIDE (Other)

Enrollment

Locations

Arms

116.5

Actual Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer	Other: Flexible Fiber-based CO2 Laser, Quality of Life forms Other: electrocautery resection and quality of life forms	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

68 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 1, 2011

Actual Primary Completion Date :

Jan 13, 2021

Actual Study Completion Date :

Jan 13, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Flexible Fiber-based CO2 Laser In the CO2 excised group, the resection will be performed at 15W, at a distance of 1cm from the tissue. Here too, if required, the bipolar will be used to achieve hemostasis The study will focus on post operative pain and quality of life outcomes for both surgical interventions.	Other: Flexible Fiber-based CO2 Laser, Quality of Life forms . 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. The secondary outcomes will be measured pre-operatively and post-operatively using the University of Washington Quality of Life questionnaire specific for head and neck version 4 (UW-QOL version 4) and the Performance Status Scale for head and neck cancer (PPS-HN) on days 7, 14 and 28. Other secondary aims will be measured intra-operatively and time to return to work and time to normal diet will be measured during timeframes of POD 1, 3, 7,14, 21 and 28.
Experimental: electrocautery resection In the electrocautery excised group, the cut and coagulation modes used will be each at 25 Malis power setting. First, cut mode will be used to mark out the lesion. Subsequently, coagulation mode will be used for excision. Bipolar cautery will then be used at 25 Malis for hemostasis. The study will focus on post operative pain and quality of life outcomes for both surgical interventions.	Other: electrocautery resection and quality of life forms 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. The secondary outcomes will be measured pre-operatively and post-operatively using the University of Washington Quality of Life questionnaire specific for head and neck version 4 (UW-QOL version 4) and the Performance Status Scale for head and neck cancer (PPS-HN) on days 7, 14 and 28. Other secondary aims will be measured intra-operatively and time to return to work and time to normal diet will be measured during timeframes of POD 1, 3, 7,14, 21 and 28.

Arm

Intervention/Treatment

Experimental: Flexible Fiber-based CO2 Laser

In the CO2 excised group, the resection will be performed at 15W, at a distance of 1cm from the tissue. Here too, if required, the bipolar will be used to achieve hemostasis The study will focus on post operative pain and quality of life outcomes for both surgical interventions.

Other: Flexible Fiber-based CO2 Laser, Quality of Life forms

. 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. The secondary outcomes will be measured pre-operatively and post-operatively using the University of Washington Quality of Life questionnaire specific for head and neck version 4 (UW-QOL version 4) and the Performance Status Scale for head and neck cancer (PPS-HN) on days 7, 14 and 28. Other secondary aims will be measured intra-operatively and time to return to work and time to normal diet will be measured during timeframes of POD 1, 3, 7,14, 21 and 28.

Experimental: electrocautery resection

In the electrocautery excised group, the cut and coagulation modes used will be each at 25 Malis power setting. First, cut mode will be used to mark out the lesion. Subsequently, coagulation mode will be used for excision. Bipolar cautery will then be used at 25 Malis for hemostasis. The study will focus on post operative pain and quality of life outcomes for both surgical interventions.

Other: electrocautery resection and quality of life forms

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. The secondary outcomes will be measured pre-operatively and post-operatively using the University of Washington Quality of Life questionnaire specific for head and neck version 4 (UW-QOL version 4) and the Performance Status Scale for head and neck cancer (PPS-HN) on days 7, 14 and 28. Other secondary aims will be measured intra-operatively and time to return to work and time to normal diet will be measured during timeframes of POD 1, 3, 7,14, 21 and 28.

Outcome Measures

Primary Outcome Measures

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 [1 month]
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.

Secondary Outcome Measures

to evaluate differences between the two surgical modalities [1 month]
in terms of intra-operative parameters, postoperative quality of life and cost effectiveness will be measured intra-operatively and time to return to work and time to normal diet will be measured during timeframes of POD 1, 3, 7,14, 21 and 28.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memoral Sloan Kettering Cancer Center	Basking Ridge	New Jersey	United States
2	Memoral Sloan Kettering Monmouth	Middletown	New Jersey	United States	07748
3	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
4	Memorial Sloan Kettering Rockville Centre	Rockville Centre	New York	United States	11570