Head and Neck CancerNCT01355926
A Single Center Randomized Controlled Trial Assessing Pain and Quality of Life Following Surgery
A study testing Flexible Fiber-based CO2 Laser, Quality of Life forms and electrocautery resection and quality of life forms in people with Head and Neck Cancer, run by Memorial Sloan Kettering Cancer Center at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Flexible Fiber-based CO2 Laser, Quality of Life forms and electrocautery resection and quality of life forms
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 4 sitesUnited States
- Study dates
- May 2011to 13 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- Patients with previous Head and Neck radiation
- Pregnant or lactating female patients.
- Patients with oral cavity squamous cell cancer requiring neck dissection
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Memoral Sloan Kettering Cancer Center
Basking Ridge, New Jersey
Memoral Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Rockville Centre
Rockville Centre, New York, 11570
About this study
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
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.
- Conditions
- Head and Neck Cancer
- Being tested
- Flexible Fiber-based CO2 Laser, Quality of Life forms, electrocautery resection and quality of life forms
- Keywords
- Flexible Fiber-based CO2 Laser, Monopolar Cautery, Oral Cavity Lesions, Quality of life, Assessing Pain, 11-034
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexible Fiber-based CO2 Laser, Quality of Life formsOther
. 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.
electrocautery resection and quality of life formsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Flexible Fiber-based CO2 Laser | Experimental | 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. Receives: Other: Flexible Fiber-based CO2 Laser, Quality of Life forms |
| electrocautery resection | Experimental | 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. Receives: Other: electrocautery resection and quality of life forms |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: 1 month
Secondary outcomes (1)
to evaluate differences between the two surgical modalities
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2011 (estimated)
- Study startMay 2011
- Primary completion13 Jan 2021
- Study completion13 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- OMNIGUIDE
- Responsible party
- Sponsor
- Investigators
- Ian Ganly, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01355926
- Sponsor's protocol ID
- 11-034
- Status last verified
- Jan 2021
- First submitted
- 16 May 2011
- Last updated
- 15 Jan 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01355926
- Acronym / sponsor ID
- 11-034
- Conditions
- Head and Neck Cancer
- Keywords
- Flexible Fiber-based CO2 Laser, Monopolar Cautery, Oral Cavity Lesions, Quality of life, Assessing Pain, 11-034
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- OMNIGUIDE
- Study start
- May 2011 (actual)
- Primary completion
- 13 Jan 2021 (actual)
- Study completion
- 13 Jan 2021 (actual)
- First posted
- 18 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flexible Fiber-based CO2 Laser | Experimental | Other: Flexible Fiber-based CO2 Laser, Quality of Life formsIn 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. |
| electrocautery resection | Experimental | Other: electrocautery resection and quality of life formsIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients with previous Head and Neck radiation
- Pregnant or lactating female patients.
- Patients with oral cavity squamous cell cancer requiring neck dissection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Flexible Fiber-based CO2 Laser |
| electrocautery resection and quality of life formsPost 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. | Other | electrocautery resection |
Primary outcome
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
Time frame: 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.
1 secondary outcome
to evaluate differences between the two surgical modalities
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ian Ganly, MD principal investigator
Memorial Sloan Kettering Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flexible Fiber-based CO2 Laser, Quality of Life forms and electrocautery resection and quality of life forms in people with Head and Neck Cancer, run by Memorial Sloan Kettering Cancer Center at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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 (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2021.