Breast CancerPhase 2NCT01204242
IRB-HSR# 13957: IV Lidocaine for Patients Undergoing Primary Breast Cancer Surgery:
A Phase 2 study testing Lidocaine in people with Breast Cancer, run by University of Virginia at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a local anesthetic drug (lidocaine) given during anesthesia intravenously (IV) through a needle in your vein,), can: 1. Help decrease pain after surgery. 2. Have you need less pain medication. 3. Have less side effects like nausea and vomiting following your surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2009to 8 Nov 2018
- Phase
- Phase 2
- 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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- informed consent
- age older than 18 to 80 years (inclusive)
- scheduled for mastectomy because of breast cancer
- American Society of Anesthesiologists (ASA) physical classification classes I - III
Who cannot join
- Allergy to local anesthetics, fentanyl or morphine
- severe cardiovascular disease (myocardial infarction within 6 months), profoundly decreased left ventricular function (ejection fraction <40%) or high-grade arrhythmias
- severe liver disease (known AST or ALT or billirubin >2.5 times the upper limit of normal)
- renal impairment (creatinine clearance less than 60)
- pregnant or breast feeding
- patient is enrolled in another study or have been in one in the last 30 days
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Health System
Charlottesville, Virginia, 22908
About this study
Official title: IRB-HSR# 13957: IV Lidocaine for Patients Undergoing Primary Breast Cancer Surgery: Effects on Postoperative Recovery and Cancer Recurrence
The purpose of this study is to determine whether a local anesthetic drug (lidocaine) given during anesthesia intravenously (IV) through a needle in your vein,), can:
- Help decrease pain after surgery.
- Have you need less pain medication.
- Have less side effects like nausea and vomiting following your surgery.
- Help to prevent chronic pain.
- Affect recurrence of cancer after surgery.
Read the detailed description
Pain after breast surgery is usually treated with narcotics; however, these are associated with a high incidence of side effects such as itching, nausea and vomiting, constipation, urinary retention and dizziness. Another modality for pain control is regional anesthesia; thoracic paravertebral blocks [TPVB] using local anesthetics are particularly appealing for breast surgery. They provide good pain control, possibly blunting surgical stress response, and decrease the need for anesthetic agent. However, TPVB are not widely used, and the inherent risk associated with their placement, such as pneumothorax, nerve injury, bleeding and infection, makes them less appealing to patients. From a pain management point of view, paravertebral blocks may be the optimal approach for reducing pain and opiate consumption after breast cancer surgery. In addition, retrospective data suggest a reduction in cancer recurrence if this technique is used. Unfortunately, this effective technique is not widely performed because of the risk of pneumothorax and is only used in some centers. Our intent is to study an alternative approach with fewer risks.
In this study, we will test the ability of intravenous lidocaine to provide pain relief after breast surgery. We base our hypothesis on a number of previous trials showing significant benefits of intravenous local anesthetics in the setting of abdominal surgery1-4.
Approximately 30 to 50% of patients will develop chronic pain following mastectomy5,6. It has been suggested that adequately treating pain in the immediate perioperative period will prevent chronic pain. Specifically, application of EMLA (local anesthetic) cream perioperatively during breast surgery has been shown to reduce the incidence of chronic pain development7. Perioperative administration of intravenous lidocaine may offer similar benefits. Therefore, we will study the incidence of chronic pain in our population after 6 months.
Finally, anesthetic choice during primary surgical intervention for cancer may affect recurrence and metastasis. A recent retrospective study suggests a profound reduction in recurrence in breast cancer patients receiving regional + general anesthesia as compared with general alone9. Similar data have been published in abstract form regarding recurrence after prostate surgery10. Also, Christopherson et al studied the long-term survival of 177 patients after resection of colon cancer in a trial of general anesthesia with and without epidural anesthesia and analgesia supplementation for resection of colon cancer. Epidural supplementation was associated with enhanced survival among patients without metastases before 1.46 years8. Although the mechanisms of this beneficial effect are unclear, attenuation of the surgical stress response, modulation of the inflammatory system, and/or decreased requirement for volatile anesthetics and opiates by regional anesthesia are possible mechanisms11. For example, the neural inputs activated during surgical stress may result in activation of promalignant pathways. Morphine has been shown to promote angiogenesis in a model of breast cancer, a key step in tumor development12. In addition, opiates interfere with natural killer cell function13. It is conceivable that the beneficial effect on recurrence might derive from low systemic level of local anesthetics attained during regional anesthesia. A number of studies have demonstrated significant reduction in opiate requirements and a decrease in the magnitude of stress response when local anesthetics are used intravenously1,3,4. If so, systemic administration would be a safer and a simpler way to reach the same goal. We therefore will compare the effect of local anesthetics given intravenously as compared with placebo on cancer recurrence rate.
- Conditions
- Breast Cancer
- Being tested
- Placebo, Lidocaine
- Keywords
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called xylocaine
ALL subjects will receive lidocaine up to 1.5mg/kg IV (in the vein) as a rapid injection.
Then the continuous IV infusion of the study medication (containing lidocaine 8 mg/ml or placebo) will be started and will continue for up to two hours in the recovery room.
LidocaineDrug
Also called xylocaine
ALL subjects will receive lidocaine up to 1.5mg/kg IV (in the vein) as a rapid injection.
Then the continuous IV infusion of the study medication (containing lidocaine 8 mg/ml or placebo) will be started and will continue for up to two hours in the recovery room.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | ALL subjects will receive lidocaine up to 1.5mg/kg IV (in the vein) as a rapid injection.
Then the continuous IV infusion of the study medication (containing lidocaine 8 mg/ml or placebo) will be started and will continue for up to two hours in the recovery room. Receives: Drug: Placebo |
| Lidocaine | Experimental | ALL subjects will receive lidocaine up to 1.5mg/kg IV (in the vein) as a rapid injection.
Then the continuous IV infusion of the study medication (containing lidocaine 8 mg/ml or placebo) will be started and will continue for up to two hours in the recovery room. Receives: Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
opiate consumption
We hypothesize that intraoperative use of intravenous lidocaine (as compared with placebo) will result in: decreased opiate consumption (primary endpoint), less pain, less fatigue and earlier postoperative discharge.
Measured: hospital discharge/ days 0-7
Secondary outcomes (2)
chronic pain
We hypothesize that patients receiving IV lidocaine will report less pain than those in the placebo group at 6 months following surgery.
Measured: 6 months after surgery
cancer recurrence
We hypothesize that patients in the IV lidocaine group will have a lower rate of cancer recurrence than those in the placebo group at 5 years following surgery.
Measured: yearly for 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2010 (estimated)
- Study start1 Aug 2009
- Primary completion8 Nov 2018
- Study completion8 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Tiouririne, MD, University of Virginia
- Investigators
- Mohammed Tiouririne, MD, Principal investigator, UVA Dept of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01204242
- Sponsor's protocol ID
- 13957
- Status last verified
- Mar 2022
- First submitted
- 15 Sep 2010
- Last updated
- 24 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Kaba A, Laurent SR, Detroz BJ, Sessler DI, Durieux ME, Lamy ML, Joris JL. Intravenous lidocaine infusion facilitates acute rehabilitation after laparoscopic colectomy. Anesthesiology. 2007 Jan;106(1):11-8; discussion 5-6. doi: 10.1097/00000542-200701000-00007.
PubMed 17197840Herroeder S, Pecher S, Schonherr ME, Kaulitz G, Hahnenkamp K, Friess H, Bottiger BW, Bauer H, Dijkgraaf MG, Durieux ME, Hollmann MW. Systemic lidocaine shortens length of hospital stay after colorectal surgery: a double-blinded, randomized, placebo-controlled trial. Ann Surg. 2007 Aug;246(2):192-200. doi: 10.1097/SLA.0b013e31805dac11.
PubMed 17667496Groudine SB, Fisher HA, Kaufman RP Jr, Patel MK, Wilkins LJ, Mehta SA, Lumb PD. Intravenous lidocaine speeds the return of bowel function, decreases postoperative pain, and shortens hospital stay in patients undergoing radical retropubic prostatectomy. Anesth Analg. 1998 Feb;86(2):235-9. doi: 10.1097/00000539-199802000-00003.
PubMed 9459225Cassuto J, Wallin G, Hogstrom S, Faxen A, Rimback G. Inhibition of postoperative pain by continuous low-dose intravenous infusion of lidocaine. Anesth Analg. 1985 Oct;64(10):971-4.
PubMed 3898920Wallace MS, Wallace AM, Lee J, Dobke MK. Pain after breast surgery: a survey of 282 women. Pain. 1996 Aug;66(2-3):195-205. doi: 10.1016/0304-3959(96)03064-3.
PubMed 8880841Jung BF, Ahrendt GM, Oaklander AL, Dworkin RH. Neuropathic pain following breast cancer surgery: proposed classification and research update. Pain. 2003 Jul;104(1-2):1-13. doi: 10.1016/s0304-3959(03)00241-0. No abstract available.
PubMed 12855309Fassoulaki A, Sarantopoulos C, Melemeni A, Hogan Q. EMLA reduces acute and chronic pain after breast surgery for cancer. Reg Anesth Pain Med. 2000 Jul-Aug;25(4):350-5. doi: 10.1053/rapm.2000.7812.
PubMed 10925929Christopherson R, James KE, Tableman M, Marshall P, Johnson FE. Long-term survival after colon cancer surgery: a variation associated with choice of anesthesia. Anesth Analg. 2008 Jul;107(1):325-32. doi: 10.1213/ane.0b013e3181770f55.
PubMed 18635504Exadaktylos AK, Buggy DJ, Moriarty DC, Mascha E, Sessler DI. Can anesthetic technique for primary breast cancer surgery affect recurrence or metastasis? Anesthesiology. 2006 Oct;105(4):660-4. doi: 10.1097/00000542-200610000-00008.
PubMed 17006061Biki B MD, Sessler DI, Mascha E, Buggy DJ: Can Anaesthetic Technique for Radical Prostatectomy Surgery Affect Recurrence or Metastasis?, ASA Annual Meeting American Society of Anesthesiologists. San Francisco, 2007
Ben-Eliyahu S, Page GG, Yirmiya R, Shakhar G. Evidence that stress and surgical interventions promote tumor development by suppressing natural killer cell activity. Int J Cancer. 1999 Mar 15;80(6):880-8. doi: 10.1002/(sici)1097-0215(19990315)80:63.0.co;2-y.
PubMed 10074922Farooqui M, Li Y, Rogers T, Poonawala T, Griffin RJ, Song CW, Gupta K. COX-2 inhibitor celecoxib prevents chronic morphine-induced promotion of angiogenesis, tumour growth, metastasis and mortality, without compromising analgesia. Br J Cancer. 2007 Dec 3;97(11):1523-31. doi: 10.1038/sj.bjc.6604057. Epub 2007 Oct 30.
PubMed 17971769Eisenstein TK, Hilburger ME. Opioid modulation of immune responses: effects on phagocyte and lymphoid cell populations. J Neuroimmunol. 1998 Mar 15;83(1-2):36-44. doi: 10.1016/s0165-5728(97)00219-1.
PubMed 9610671Apfel CC, Korttila K, Abdalla M, Kerger H, Turan A, Vedder I, Zernak C, Danner K, Jokela R, Pocock SJ, Trenkler S, Kredel M, Biedler A, Sessler DI, Roewer N; IMPACT Investigators. A factorial trial of six interventions for the prevention of postoperative nausea and vomiting. N Engl J Med. 2004 Jun 10;350(24):2441-51. doi: 10.1056/NEJMoa032196.
PubMed 15190136Terkawi AS, Durieux ME, Gottschalk A, Brenin D, Tiouririne M. Effect of intravenous lidocaine on postoperative recovery of patients undergoing mastectomy: a double-blind, placebo-controlled randomized trial. Reg Anesth Pain Med. 2014 Nov-Dec;39(6):472-7. doi: 10.1097/AAP.0000000000000140.
PubMed 25275577
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IRB-HSR# 13957: IV Lidocaine for Patients Undergoing Primary Breast Cancer Surgery: Effects on Postoperative Recovery and Cancer Recurrence
- ClinicalTrials.gov ID
- NCT01204242
- Acronym / sponsor ID
- 13957
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 1 Aug 2009 (actual)
- Primary completion
- 8 Nov 2018 (actual)
- Study completion
- 8 Nov 2018 (actual)
- First posted
- 17 Sep 2010 (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 determine whether a local anesthetic drug (lidocaine) given during anesthesia intravenously (IV) through a needle in your vein,), can:
- Help decrease pain after surgery.
- Have you need less pain medication.
- Have less side effects like nausea and vomiting following your surgery.
- Help to prevent chronic pain.
- Affect recurrence of cancer after surgery.
Detailed description
Pain after breast surgery is usually treated with narcotics; however, these are associated with a high incidence of side effects such as itching, nausea and vomiting, constipation, urinary retention and dizziness. Another modality for pain control is regional anesthesia; thoracic paravertebral blocks [TPVB] using local anesthetics are particularly appealing for breast surgery. They provide good pain control, possibly blunting surgical stress response, and decrease the need for anesthetic agent. However, TPVB are not widely used, and the inherent risk associated with their placement, such as pneumothorax, nerve injury, bleeding and infection, makes them less appealing to patients. From a pain management point of view, paravertebral blocks may be the optimal approach for reducing pain and opiate consumption after breast cancer surgery. In addition, retrospective data suggest a reduction in cancer recurrence if this technique is used. Unfortunately, this effective technique is not widely performed because of the risk of pneumothorax and is only used in some centers. Our intent is to study an alternative approach with fewer risks.
In this study, we will test the ability of intravenous lidocaine to provide pain relief after breast surgery. We base our hypothesis on a number of previous trials showing significant benefits of intravenous local anesthetics in the setting of abdominal surgery1-4.
Approximately 30 to 50% of patients will develop chronic pain following mastectomy5,6. It has been suggested that adequately treating pain in the immediate perioperative period will prevent chronic pain. Specifically, application of EMLA (local anesthetic) cream perioperatively during breast surgery has been shown to reduce the incidence of chronic pain development7. Perioperative administration of intravenous lidocaine may offer similar benefits. Therefore, we will study the incidence of chronic pain in our population after 6 months.
Finally, anesthetic choice during primary surgical intervention for cancer may affect recurrence and metastasis. A recent retrospective study suggests a profound reduction in recurrence in breast cancer patients receiving regional + general anesthesia as compared with general alone9. Similar data have been published in abstract form regarding recurrence after prostate surgery10. Also, Christopherson et al studied the long-term survival of 177 patients after resection of colon cancer in a trial of general anesthesia with and without epidural anesthesia and analgesia supplementation for resection of colon cancer. Epidural supplementation was associated with enhanced survival among patients without metastases before 1.46 years8. Although the mechanisms of this beneficial effect are unclear, attenuation of the surgical stress response, modulation of the inflammatory system, and/or decreased requirement for volatile anesthetics and opiates by regional anesthesia are possible mechanisms11. For example, the neural inputs activated during surgical stress may result in activation of promalignant pathways. Morphine has been shown to promote angiogenesis in a model of breast cancer, a key step in tumor development12. In addition, opiates interfere with natural killer cell function13. It is conceivable that the beneficial effect on recurrence might derive from low systemic level of local anesthetics attained during regional anesthesia. A number of studies have demonstrated significant reduction in opiate requirements and a decrease in the magnitude of stress response when local anesthetics are used intravenously1,3,4. If so, systemic administration would be a safer and a simpler way to reach the same goal. We therefore will compare the effect of local anesthetics given intravenously as compared with placebo on cancer recurrence rate.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboALL subjects will receive lidocaine up to 1.5mg/kg IV (in the vein) as a rapid injection. Then the continuous IV infusion of the study medication (containing lidocaine 8 mg/ml or placebo) will be started and will continue for up to two hours in the recovery room. |
| Lidocaine | Experimental | Drug: LidocaineALL subjects will receive lidocaine up to 1.5mg/kg IV (in the vein) as a rapid injection. Then the continuous IV infusion of the study medication (containing lidocaine 8 mg/ml or placebo) will be started and will continue for up to two hours in the recovery room. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- informed consent
- age older than 18 to 80 years (inclusive)
- scheduled for mastectomy because of breast cancer
- American Society of Anesthesiologists (ASA) physical classification classes I - III
Key exclusion criteria (6 listed)
- Allergy to local anesthetics, fentanyl or morphine
- severe cardiovascular disease (myocardial infarction within 6 months), profoundly decreased left ventricular function (ejection fraction <40%) or high-grade arrhythmias
- severe liver disease (known AST or ALT or billirubin >2.5 times the upper limit of normal)
- renal impairment (creatinine clearance less than 60)
- pregnant or breast feeding
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 |
|---|---|---|
| PlaceboAlso: xylocaineALL subjects will receive lidocaine up to 1.5mg/kg IV (in the vein) as a rapid injection. Then the continuous IV infusion of the study medication (containing lidocaine 8 mg/ml or placebo) will be started and will continue for up to two hours in the recovery room. | Drug | Placebo |
| LidocaineAlso: xylocaineALL subjects will receive lidocaine up to 1.5mg/kg IV (in the vein) as a rapid injection. Then the continuous IV infusion of the study medication (containing lidocaine 8 mg/ml or placebo) will be started and will continue for up to two hours in the recovery room. | Drug | Lidocaine |
Primary outcome
opiate consumption
Time frame: hospital discharge/ days 0-7
We hypothesize that intraoperative use of intravenous lidocaine (as compared with placebo) will result in: decreased opiate consumption (primary endpoint), less pain, less fatigue and earlier postoperative discharge.
2 secondary outcomes
chronic pain
Time frame: 6 months after surgery
cancer recurrence
Time frame: yearly for 5 years after surgery
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 24 Mar 2022.
- Background: PubMed 17197840Kaba A, Laurent SR, Detroz BJ, Sessler DI, Durieux ME, Lamy ML, Joris JL. Intravenous lidocaine infusion facilitates acute rehabilitation after laparoscopic colectomy. Anesthesiology. 2007 Jan;106(1):11-8; discussion 5-6. doi: 10.1097/00000542-200701000-00007.
- Background: PubMed 17667496Herroeder S, Pecher S, Schonherr ME, Kaulitz G, Hahnenkamp K, Friess H, Bottiger BW, Bauer H, Dijkgraaf MG, Durieux ME, Hollmann MW. Systemic lidocaine shortens length of hospital stay after colorectal surgery: a double-blinded, randomized, placebo-controlled trial. Ann Surg. 2007 Aug;246(2):192-200. doi: 10.1097/SLA.0b013e31805dac11.
- Background: PubMed 9459225Groudine SB, Fisher HA, Kaufman RP Jr, Patel MK, Wilkins LJ, Mehta SA, Lumb PD. Intravenous lidocaine speeds the return of bowel function, decreases postoperative pain, and shortens hospital stay in patients undergoing radical retropubic prostatectomy. Anesth Analg. 1998 Feb;86(2):235-9. doi: 10.1097/00000539-199802000-00003.
- Background: PubMed 3898920Cassuto J, Wallin G, Hogstrom S, Faxen A, Rimback G. Inhibition of postoperative pain by continuous low-dose intravenous infusion of lidocaine. Anesth Analg. 1985 Oct;64(10):971-4.
- Background: PubMed 8880841Wallace MS, Wallace AM, Lee J, Dobke MK. Pain after breast surgery: a survey of 282 women. Pain. 1996 Aug;66(2-3):195-205. doi: 10.1016/0304-3959(96)03064-3.
- Background: PubMed 12855309Jung BF, Ahrendt GM, Oaklander AL, Dworkin RH. Neuropathic pain following breast cancer surgery: proposed classification and research update. Pain. 2003 Jul;104(1-2):1-13. doi: 10.1016/s0304-3959(03)00241-0. No abstract available.
- Background: PubMed 10925929Fassoulaki A, Sarantopoulos C, Melemeni A, Hogan Q. EMLA reduces acute and chronic pain after breast surgery for cancer. Reg Anesth Pain Med. 2000 Jul-Aug;25(4):350-5. doi: 10.1053/rapm.2000.7812.
- Background: PubMed 18635504Christopherson R, James KE, Tableman M, Marshall P, Johnson FE. Long-term survival after colon cancer surgery: a variation associated with choice of anesthesia. Anesth Analg. 2008 Jul;107(1):325-32. doi: 10.1213/ane.0b013e3181770f55.
- Background: PubMed 17006061Exadaktylos AK, Buggy DJ, Moriarty DC, Mascha E, Sessler DI. Can anesthetic technique for primary breast cancer surgery affect recurrence or metastasis? Anesthesiology. 2006 Oct;105(4):660-4. doi: 10.1097/00000542-200610000-00008.
- BackgroundBiki B MD, Sessler DI, Mascha E, Buggy DJ: Can Anaesthetic Technique for Radical Prostatectomy Surgery Affect Recurrence or Metastasis?, ASA Annual Meeting American Society of Anesthesiologists. San Francisco, 2007
- Background: PubMed 10074922Ben-Eliyahu S, Page GG, Yirmiya R, Shakhar G. Evidence that stress and surgical interventions promote tumor development by suppressing natural killer cell activity. Int J Cancer. 1999 Mar 15;80(6):880-8. doi: 10.1002/(sici)1097-0215(19990315)80:63.0.co;2-y.
- Background: PubMed 17971769Farooqui M, Li Y, Rogers T, Poonawala T, Griffin RJ, Song CW, Gupta K. COX-2 inhibitor celecoxib prevents chronic morphine-induced promotion of angiogenesis, tumour growth, metastasis and mortality, without compromising analgesia. Br J Cancer. 2007 Dec 3;97(11):1523-31. doi: 10.1038/sj.bjc.6604057. Epub 2007 Oct 30.
- Individual participant dataSharing planned: No
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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.
Mohammed Tiouririne, MD principal investigator
UVA Dept of Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lidocaine in people with Breast Cancer, run by University of Virginia 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 4 inclusion and 6 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 24 Mar 2022. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 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?
opiate consumption (time frame: hospital discharge/ days 0-7). 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 NCT01204242, which also lists 15 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 24 Mar 2022.