Breast Cancer SurgeryPhase 3NCT00852683
The Effects of Peri-Operative Pregabalin on Post-Operative Pain Following Breast Cancer Surgery With Axillary Node Dissection: A Pilot Study
A Phase 3 study testing Pregabalin in people with Breast Cancer Surgery and Post Operative Pain, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
Breast cancer is a devastating disease. Some women with breast cancer undergo surgery to remove the breast and lymph nodes in the axilla (armpit). Unfortunately, surgery of this type is associated with pain both in the days immediately following the operation and in the long term. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Breast Cancer Surgery, Post Operative Pain
- What is being tested?
- Pregabalin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- May 2008to Dec 2013
- Phase
- Phase 3
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients 18-60 years of age, ASA I-III undergoing breast surgery with axillary dissection for the treatment of breast cancer will be considered eligible for the study.
- Informed consent for the study will be obtained prior to surgery.
Who cannot join
- The following persons will not be considered for inclusion in the study:
- Persons undergoing breast surgery for breast cancer without axillary dissection.
- Persons undergoing cosmetic breast surgery.
- Persons undergoing concurrent breast reconstruction.
- Persons undergoing reconstruction within 12 months of surgery.
- Persons with a history of allergy to gabapentin or pregabalin.
Show all 13Show fewer
- Persons with a history of allergy to morphine, nonsteroidal antiinflammatory drugs, acetaminophen or oxycodone.
- Persons who are or may be pregnant.
- Persons with a BMI >40.
- Persons with severe organ dysfunction such as liver and renal failure.
- Persons receiving greater than or equal to 30 mg per day of morphine (or equivalent opioid) for pre-existing pain conditions.
- Persons previously on gabapentin or pregabalin within 3 months of surgery.
- Persons with a history of drug abuse. 13) Persons who are unable to communicate in English.
Trial locations and contacts
1 site in 1 country.
About this study
Breast cancer is a devastating disease. Some women with breast cancer undergo surgery to remove the breast and lymph nodes in the axilla (armpit). Unfortunately, surgery of this type is associated with pain both in the days immediately following the operation and in the long term. Pain that continues for more than three months after surgery is known as chronic pain and affects as many as 1/5 to more than ½ of patients having this surgery. Often this pain is of a particular type known as neuropathic pain. There have been studies demonstrating that the intensity of pain after surgery may be related to the likelihood of developing chronic pain. It is important to develop methods to reduce acute pain after breast cancer surgery and to reduce chronic pain for breast cancer survivors.
Pregabalin is a medication used in the treatment of chronic pain. It has been shown to be effective for neuropathic pain. There has also been one study demonstrating its effectiveness in reducing pain after dental extraction. We are interested in determining whether pregabalin taken for 14 days starting the day of surgery will reduce acute (short term) pain and chronic pain from this type of breast cancer surgery.
In order to test ability of pregabalin for the reduction of chronic pain it may be necessary to follow a large number of patients for up to one year after surgery. This may require studying patients in more than one institution. Prior to starting such a large study we are proposing a pilot or preliminary study. This study will follow a smaller group of participants (68) for 6 months. From the pilot study we will determine the effect of pregabalin on acute pain and logistic and statistical information required for the full study. We will randomly assign participants to receive pregabalin or placebo (sugar pills) for twice daily for 14 days starting one hour before surgery. We will monitor the participants' pain at one hour after surgery, 24 hours after surgery, one week, two weeks, three months and six months after surgery. We will also monitor for a number of other parameters such as medication side effects and the need for other pain medications. Recruitment of study participants is expected to take 6-7 months.
- Conditions
- Breast Cancer Surgery, Post Operative Pain
- Being tested
- Pregabalin, Placebo
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
75 mg twice a day
PlaceboDrug
75 mg twice a day
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Drug: Pregabalin |
| B | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be reduction in Numeric Rating Score (22, 23) at rest (NRS-R) and with movement (NRS-M) 24 hours after surgery. NRS-M is defined as pain with cough or deep inspiration, whichever is greatest.
Measured: 24 hours
Secondary outcomes (1)
Incidence of chronic post-mastectomy pain at 3 months defined as persistent pain or discomfort not present prior to surgery and not present as a result of new or recurrent tumour growth.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2009 (estimated)
- Study startMay 2008
- Primary completionApr 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer SurgeryStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter MacDougall, Nova Scotia Health Authority
- Investigators
- Peter MacDougall, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00852683
- Sponsor's protocol ID
- CDHA-RS/2007-374
- Status last verified
- Mar 2014
- First submitted
- 28 Mar 2008
- Last updated
- 7 Mar 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Peri-Operative Pregabalin on Post-Operative Pain Following Breast Cancer Surgery With Axillary Node Dissection: A Pilot Study
- ClinicalTrials.gov ID
- NCT00852683
- Acronym / sponsor ID
- CDHA-RS/2007-374
- Conditions
- Breast Cancer Surgery, Post Operative Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Apr 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 27 Feb 2009 (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.
Breast cancer is a devastating disease. Some women with breast cancer undergo surgery to remove the breast and lymph nodes in the axilla (armpit). Unfortunately, surgery of this type is associated with pain both in the days immediately following the operation and in the long term. Pain that continues for more than three months after surgery is known as chronic pain and affects as many as 1/5 to more than ½ of patients having this surgery. Often this pain is of a particular type known as neuropathic pain. There have been studies demonstrating that the intensity of pain after surgery may be related to the likelihood of developing chronic pain. It is important to develop methods to reduce acute pain after breast cancer surgery and to reduce chronic pain for breast cancer survivors.
Pregabalin is a medication used in the treatment of chronic pain. It has been shown to be effective for neuropathic pain. There has also been one study demonstrating its effectiveness in reducing pain after dental extraction. We are interested in determining whether pregabalin taken for 14 days starting the day of surgery will reduce acute (short term) pain and chronic pain from this type of breast cancer surgery.
In order to test ability of pregabalin for the reduction of chronic pain it may be necessary to follow a large number of patients for up to one year after surgery. This may require studying patients in more than one institution. Prior to starting such a large study we are proposing a pilot or preliminary study. This study will follow a smaller group of participants (68) for 6 months. From the pilot study we will determine the effect of pregabalin on acute pain and logistic and statistical information required for the full study. We will randomly assign participants to receive pregabalin or placebo (sugar pills) for twice daily for 14 days starting one hour before surgery. We will monitor the participants' pain at one hour after surgery, 24 hours after surgery, one week, two weeks, three months and six months after surgery. We will also monitor for a number of other parameters such as medication side effects and the need for other pain medications. Recruitment of study participants is expected to take 6-7 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Pregabalin |
| B | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients 18-60 years of age, ASA I-III undergoing breast surgery with axillary dissection for the treatment of breast cancer will be considered eligible for the study.
- Informed consent for the study will be obtained prior to surgery.
Key exclusion criteria (13 listed)
- Persons undergoing breast surgery for breast cancer without axillary dissection.
- Persons undergoing cosmetic breast surgery.
- Persons undergoing concurrent breast reconstruction.
- Persons undergoing reconstruction within 12 months of surgery.
- Persons with a history of allergy to gabapentin or pregabalin.
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 |
|---|---|---|
| Pregabalin75 mg twice a day | Drug | A |
| Placebo75 mg twice a day | Drug | B |
Primary outcome
The primary outcome will be reduction in Numeric Rating Score (22, 23) at rest (NRS-R) and with movement (NRS-M) 24 hours after surgery. NRS-M is defined as pain with cough or deep inspiration, whichever is greatest.
Time frame: 24 hours
1 secondary outcome
Incidence of chronic post-mastectomy pain at 3 months defined as persistent pain or discomfort not present prior to surgery and not present as a result of new or recurrent tumour growth.
Time frame: 3 months
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 7 Mar 2014.
- Capital District Health AuthorityLink 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.
Peter MacDougall principal investigator
Nova Scotia Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pregabalin in people with Breast Cancer Surgery and Post Operative Pain, run by Nova Scotia Health Authority at 1 site in Canada.
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 2 inclusion and 13 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 7 Mar 2014. 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 Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The primary outcome will be reduction in Numeric Rating Score (22, 23) at rest (NRS-R) and with movement (NRS-M) 24 hours after surgery. NRS-M is defined as pain with cough or deep inspiration, whichever is greatest. (time frame: 24 hours). 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 7 Mar 2014.