Head and Neck CancerPhase 4NCT03714867
Pre-Operative Pregabalin for Post-Operative Pain in Head and Neck Cancer Surgery
A Phase 4 study testing Pregabalin 150mg in people with Head and Neck Cancer and Pain, Postoperative, run by Augusta University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate and reduce pain and improve quality of life in patients being treated for head and neck cancer with primary tumor resection and bilateral neck dissections. Patients will be randomly assigned to receive either pre-operative pregabalin (Lyrica) or a placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Pain, Postoperative
- What is being tested?
- Pregabalin 150mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2019to 7 Jul 2020
- Phase
- Phase 4
- 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
- English-speaking patients who are greater than eighteen years of age with a known diagnosis of head and neck cancer and are planned to undergo surgery with bilateral neck dissections will be eligible for this study.
Who cannot join
- Patients with a history of preoperative narcotic use for conditions unrelated to their head and neck cancer will be excluded.
- Patients younger than eighteen years of age, patients with previous severe adverse reaction to pregabalin (Lyrica), patients with a history of angioedema, and pregnant patients will be excluded from this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Augusta University Department of Otolaryngology-Head and Neck Surgery
Augusta, Georgia, 30912
About this study
Official title: Use of Single Dose Pre-Operative Pregabalin for Post-Operative Analgesia in Bilateral Head and Neck Cancer Surgery: A Randomized, Double-Blinded, Placebo-Controlled Trial
The purpose of this study is to evaluate and reduce pain and improve quality of life in patients being treated for head and neck cancer with primary tumor resection and bilateral neck dissections. Patients will be randomly assigned to receive either pre-operative pregabalin (Lyrica) or a placebo. Patients and investigators will be blinded to which medication patients receive, and all patients will receive the same postoperative pain medication regimen with appropriate pain treatment as needed. Patients will be asked to fill out surveys prior to surgery, while in the hospital after surgery, and at each follow-up appointment for up to 24 months.
Read the detailed description
In this study, we will utilize single-dose pre-operative administration of Lyrica (pregabalin) compared to patients who will be administered a pre-operative single-dose placebo. Pregabalin is a non-narcotic GABA analogue that has been shown to be effective for the treatment of pain associated with a variety of medical conditions. Prior studies have investigated the use of single-dose pre-operative pregabalin for analgesia in acute dental, gynecologic, endoscopic thyroidectomy, and nasal septoplasty surgical pain with encouraging results demonstrating improved overall pain scores and decreased post-operative use of narcotics. Pregabalin's use for peri-operative analgesia in head and neck cancer surgery has not been evaluated.
Patients who enroll in the study will be randomly assigned by chance to receive either a single pre-operative 150 milligram dose of pregabalin (Lyrica) or placebo in the pre-operative holding area prior to proceeding with surgery. Lyrica is a non-narcotic pain medication that has been shown to promote good control of nerve-related pain in patients. Patients who agree to enroll in the study will be asked to fill out separate questionnaires to evaluate pain and quality of life preoperatively and post-operatively.
Participants will be asked to fill out four separate questionnaires to evaluate pain and quality of life pre-operatively. Patients will be administered their respective medication, either placebo or single-dose 150 milligram concealed capsule of pregabalin, by mouth in the pre-operative holding area prior to surgery. While in the hospital after surgery, patients will be given a regimen of scheduled acetaminophen 650 milligrams every 6 hours. Planned treatment of pain will include the option of requesting oxycodone on an as-needed basis every four hours and IV morphine for breakthrough pain. Surveys will be administered and collected on a daily basis while patients are in the hospital. If patients are already utilizing other non-opioid pain medications like muscle relaxers (Flexeril, baclofen, etc.), or neuropathic pain medications (Neurontin), they will be allowed to continue these medications while inpatient provided there are no changes in dosing.
Patients will be discharged home on a seven-day course of acetaminophen with as-needed oxycodone. Outcomes surveys will then be collected at each subsequent post-operative follow up. Follow up visits will occur one week after discharge, four weeks after discharge, and then every three months until completion of the two year study period.
- Conditions
- Head and Neck Cancer, Pain, Postoperative
- Being tested
- Pregabalin 150mg, Placebo
- Keywords
- head and neck cancer, analgesia, pregabalin
- Medical subject headings
- Head and Neck Neoplasms, Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregabalin 150mgDrug
Also called Lyrica
150 mg concealed pregabalin capsule
PlaceboOther
Concealed placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Treatment arm intervention consists of patients who will be administered a single enteral dose of concealed over-encapsulated Pregabalin 150mg in the pre-operative holding area. Patients will be given a post-operative regimen of 650 mg enteral acetaminophen every 6 hours and as needed oxycodone and intravenous morphine for breakthrough pain. Receives: Drug: Pregabalin 150mg |
| Control | Placebo comparator | Treatment arm consists of patients who will be administered a single enteral dose of concealed over-encapsulated placebo capsules in the pre-operative holding area. Patients will be given a post-operative regimen of 650 mg enteral acetaminophen every 6 hours and as needed oxycodone and intravenous morphine for breakthrough pain. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Pain Inventory
Validated head and neck cancer pain scale
Measured: 2 years
Secondary outcomes (4)
Defense and Veterans Pain Rating Scale
Non-validated pain scale in head and neck cancer
Measured: 2 years
University of Washington Quality of Life Scale Version 4 (UW-QOL-4)
Validated quality of life scale in head and neck cancer
Measured: 2 years
EuroQol 5D-5L
Non-validated quality of life scale in head and neck cancer
Measured: 2 years
Inpatient morphine equivalents
Cumulative inpatient narcotic consumption
Measured: 1-7 days or longer depending on length of stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start22 Mar 2019
- Primary completion7 Jul 2020
- Study completion7 Jul 2020
Why it stopped: Inability to recruit patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention is single dose. Patients will be assigned to either treatment or placebo arms. No opportunity for crossing over will be present.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James K Byrd, MD, Principal investigator, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03714867
- Sponsor's protocol ID
- 1317015
- Status last verified
- Jul 2020
- First submitted
- 19 Oct 2018
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Hwang SH, Park IJ, Cho YJ, Jeong YM, Kang JM. The efficacy of gabapentin/pregabalin in improving pain after tonsillectomy: A meta-analysis. Laryngoscope. 2016 Feb;126(2):357-66. doi: 10.1002/lary.25636. Epub 2015 Sep 25.
PubMed 26404562Oltman J, Militsakh O, D'Agostino M, Kauffman B, Lindau R, Coughlin A, Lydiatt W, Lydiatt D, Smith R, Panwar A. Multimodal Analgesia in Outpatient Head and Neck Surgery: A Feasibility and Safety Study. JAMA Otolaryngol Head Neck Surg. 2017 Dec 1;143(12):1207-1212. doi: 10.1001/jamaoto.2017.1773.
PubMed 29049548Sanders JG, Cameron C, Dawes PJD. Gabapentin in the Management of Pain following Tonsillectomy: A Randomized Double-Blind Placebo-Controlled Trial. Otolaryngol Head Neck Surg. 2017 Nov;157(5):781-790. doi: 10.1177/0194599817719883. Epub 2017 Jul 25.
PubMed 28741425Ogawa S, Arakawa A, Hayakawa K, Yoshiyama T. Pregabalin for Neuropathic Pain: Why Benefits Could Be Expected for Multiple Pain Conditions. Clin Drug Investig. 2016 Nov;36(11):877-888. doi: 10.1007/s40261-016-0423-x.
PubMed 27448285Moore RA, Straube S, Wiffen PJ, Derry S, McQuay HJ. Pregabalin for acute and chronic pain in adults. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD007076. doi: 10.1002/14651858.CD007076.pub2.
PubMed 19588419Ben-Menachem E. Pregabalin pharmacology and its relevance to clinical practice. Epilepsia. 2004;45 Suppl 6:13-8. doi: 10.1111/j.0013-9580.2004.455003.x.
PubMed 15315511Sabatowski R, Galvez R, Cherry DA, Jacquot F, Vincent E, Maisonobe P, Versavel M; 1008-045 Study Group. Pregabalin reduces pain and improves sleep and mood disturbances in patients with post-herpetic neuralgia: results of a randomised, placebo-controlled clinical trial. Pain. 2004 May;109(1-2):26-35. doi: 10.1016/j.pain.2004.01.001.
PubMed 15082123Liebana-Hermoso S, Manzano-Moreno FJ, Vallecillo-Capilla MF, Olmedo-Gaya MV. Oral pregabalin for acute pain relief after cervicofacial surgery: a systematic review. Clin Oral Investig. 2018 Jan;22(1):119-129. doi: 10.1007/s00784-017-2272-2. Epub 2017 Nov 3.
PubMed 29101547Kim SY, Jeong JJ, Chung WY, Kim HJ, Nam KH, Shim YH. Perioperative administration of pregabalin for pain after robot-assisted endoscopic thyroidectomy: a randomized clinical trial. Surg Endosc. 2010 Nov;24(11):2776-81. doi: 10.1007/s00464-010-1045-7. Epub 2010 Apr 8.
PubMed 20376496Ringash J, Bernstein LJ, Cella D, Logemann J, Movsas B, Murphy B, Trotti A, Wells N, Yueh B, Ridge J. Outcomes toolbox for head and neck cancer research. Head Neck. 2015 Mar;37(3):425-39. doi: 10.1002/hed.23561. Epub 2015 Jan 22.
PubMed 24318166
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Single Dose Pre-Operative Pregabalin for Post-Operative Analgesia in Bilateral Head and Neck Cancer Surgery: A Randomized, Double-Blinded, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT03714867
- Acronym / sponsor ID
- 1317015
- Conditions
- Head and Neck Cancer, Pain, Postoperative
- Keywords
- head and neck cancer, analgesia, pregabalin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Inability to recruit patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- 22 Mar 2019 (actual)
- Primary completion
- 7 Jul 2020 (actual)
- Study completion
- 7 Jul 2020 (actual)
- First posted
- 22 Oct 2018 (actual)
- 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 evaluate and reduce pain and improve quality of life in patients being treated for head and neck cancer with primary tumor resection and bilateral neck dissections. Patients will be randomly assigned to receive either pre-operative pregabalin (Lyrica) or a placebo. Patients and investigators will be blinded to which medication patients receive, and all patients will receive the same postoperative pain medication regimen with appropriate pain treatment as needed. Patients will be asked to fill out surveys prior to surgery, while in the hospital after surgery, and at each follow-up appointment for up to 24 months.
Detailed description
In this study, we will utilize single-dose pre-operative administration of Lyrica (pregabalin) compared to patients who will be administered a pre-operative single-dose placebo. Pregabalin is a non-narcotic GABA analogue that has been shown to be effective for the treatment of pain associated with a variety of medical conditions. Prior studies have investigated the use of single-dose pre-operative pregabalin for analgesia in acute dental, gynecologic, endoscopic thyroidectomy, and nasal septoplasty surgical pain with encouraging results demonstrating improved overall pain scores and decreased post-operative use of narcotics. Pregabalin's use for peri-operative analgesia in head and neck cancer surgery has not been evaluated.
Patients who enroll in the study will be randomly assigned by chance to receive either a single pre-operative 150 milligram dose of pregabalin (Lyrica) or placebo in the pre-operative holding area prior to proceeding with surgery. Lyrica is a non-narcotic pain medication that has been shown to promote good control of nerve-related pain in patients. Patients who agree to enroll in the study will be asked to fill out separate questionnaires to evaluate pain and quality of life preoperatively and post-operatively.
Participants will be asked to fill out four separate questionnaires to evaluate pain and quality of life pre-operatively. Patients will be administered their respective medication, either placebo or single-dose 150 milligram concealed capsule of pregabalin, by mouth in the pre-operative holding area prior to surgery. While in the hospital after surgery, patients will be given a regimen of scheduled acetaminophen 650 milligrams every 6 hours. Planned treatment of pain will include the option of requesting oxycodone on an as-needed basis every four hours and IV morphine for breakthrough pain. Surveys will be administered and collected on a daily basis while patients are in the hospital. If patients are already utilizing other non-opioid pain medications like muscle relaxers (Flexeril, baclofen, etc.), or neuropathic pain medications (Neurontin), they will be allowed to continue these medications while inpatient provided there are no changes in dosing.
Patients will be discharged home on a seven-day course of acetaminophen with as-needed oxycodone. Outcomes surveys will then be collected at each subsequent post-operative follow up. Follow up visits will occur one week after discharge, four weeks after discharge, and then every three months until completion of the two year study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Intervention is single dose. Patients will be assigned to either treatment or placebo arms. No opportunity for crossing over will be present.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Pregabalin 150mgTreatment arm intervention consists of patients who will be administered a single enteral dose of concealed over-encapsulated Pregabalin 150mg in the pre-operative holding area. Patients will be given a post-operative regimen of 650 mg enteral acetaminophen every 6 hours and as needed oxycodone and intravenous morphine for breakthrough pain. |
| Control | Placebo comparator | Other: PlaceboTreatment arm consists of patients who will be administered a single enteral dose of concealed over-encapsulated placebo capsules in the pre-operative holding area. Patients will be given a post-operative regimen of 650 mg enteral acetaminophen every 6 hours and as needed oxycodone and intravenous morphine for breakthrough pain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- English-speaking patients who are greater than eighteen years of age with a known diagnosis of head and neck cancer and are planned to undergo surgery with bilateral neck dissections will be eligible for this study.
Key exclusion criteria (2 listed)
- Patients with a history of preoperative narcotic use for conditions unrelated to their head and neck cancer will be excluded.
- Patients younger than eighteen years of age, patients with previous severe adverse reaction to pregabalin (Lyrica), patients with a history of angioedema, and pregnant patients will be excluded from this study.
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 |
|---|---|---|
| Pregabalin 150mgAlso: Lyrica150 mg concealed pregabalin capsule | Drug | Treatment |
| PlaceboConcealed placebo capsule | Other | Control |
Primary outcome
Brief Pain Inventory
Time frame: 2 years
Validated head and neck cancer pain scale
4 secondary outcomes
Defense and Veterans Pain Rating Scale
Time frame: 2 years
University of Washington Quality of Life Scale Version 4 (UW-QOL-4)
Time frame: 2 years
EuroQol 5D-5L
Time frame: 2 years
Inpatient morphine equivalents
Time frame: 1-7 days or longer depending on length of stay
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
- Background: PubMed 26404562Hwang SH, Park IJ, Cho YJ, Jeong YM, Kang JM. The efficacy of gabapentin/pregabalin in improving pain after tonsillectomy: A meta-analysis. Laryngoscope. 2016 Feb;126(2):357-66. doi: 10.1002/lary.25636. Epub 2015 Sep 25.
- Background: PubMed 29049548Oltman J, Militsakh O, D'Agostino M, Kauffman B, Lindau R, Coughlin A, Lydiatt W, Lydiatt D, Smith R, Panwar A. Multimodal Analgesia in Outpatient Head and Neck Surgery: A Feasibility and Safety Study. JAMA Otolaryngol Head Neck Surg. 2017 Dec 1;143(12):1207-1212. doi: 10.1001/jamaoto.2017.1773.
- Background: PubMed 28741425Sanders JG, Cameron C, Dawes PJD. Gabapentin in the Management of Pain following Tonsillectomy: A Randomized Double-Blind Placebo-Controlled Trial. Otolaryngol Head Neck Surg. 2017 Nov;157(5):781-790. doi: 10.1177/0194599817719883. Epub 2017 Jul 25.
- Background: PubMed 27448285Ogawa S, Arakawa A, Hayakawa K, Yoshiyama T. Pregabalin for Neuropathic Pain: Why Benefits Could Be Expected for Multiple Pain Conditions. Clin Drug Investig. 2016 Nov;36(11):877-888. doi: 10.1007/s40261-016-0423-x.
- Background: PubMed 19588419Moore RA, Straube S, Wiffen PJ, Derry S, McQuay HJ. Pregabalin for acute and chronic pain in adults. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD007076. doi: 10.1002/14651858.CD007076.pub2.
- Background: PubMed 15315511Ben-Menachem E. Pregabalin pharmacology and its relevance to clinical practice. Epilepsia. 2004;45 Suppl 6:13-8. doi: 10.1111/j.0013-9580.2004.455003.x.
- Background: PubMed 15082123Sabatowski R, Galvez R, Cherry DA, Jacquot F, Vincent E, Maisonobe P, Versavel M; 1008-045 Study Group. Pregabalin reduces pain and improves sleep and mood disturbances in patients with post-herpetic neuralgia: results of a randomised, placebo-controlled clinical trial. Pain. 2004 May;109(1-2):26-35. doi: 10.1016/j.pain.2004.01.001.
- Background: PubMed 29101547Liebana-Hermoso S, Manzano-Moreno FJ, Vallecillo-Capilla MF, Olmedo-Gaya MV. Oral pregabalin for acute pain relief after cervicofacial surgery: a systematic review. Clin Oral Investig. 2018 Jan;22(1):119-129. doi: 10.1007/s00784-017-2272-2. Epub 2017 Nov 3.
- Background: PubMed 20376496Kim SY, Jeong JJ, Chung WY, Kim HJ, Nam KH, Shim YH. Perioperative administration of pregabalin for pain after robot-assisted endoscopic thyroidectomy: a randomized clinical trial. Surg Endosc. 2010 Nov;24(11):2776-81. doi: 10.1007/s00464-010-1045-7. Epub 2010 Apr 8.
- Background: PubMed 24318166Ringash J, Bernstein LJ, Cella D, Logemann J, Movsas B, Murphy B, Trotti A, Wells N, Yueh B, Ridge J. Outcomes toolbox for head and neck cancer research. Head Neck. 2015 Mar;37(3):425-39. doi: 10.1002/hed.23561. Epub 2015 Jan 22.
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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.
James K Byrd, MD principal investigator
Augusta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pregabalin 150mg in people with Head and Neck Cancer and Pain, Postoperative, run by Augusta University at 1 site 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 1 inclusion and 2 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: withdrawn, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Brief Pain Inventory (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03714867, which also lists 10 linked publications.
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 9 Jul 2020.