Patients Scheduled for Thoracic Surgery/Esophagectomy Will be EnrolledNCT03095157
The Emerging Role of Resolvins in the Prevention of Chronic Pain After Thoracic Surgery
A study testing fractionated marine lipid concentrate derived from anchovy and sardine oil in people with Patients Scheduled for Thoracic Surgery/Esophagectomy Will be Enrolled and Persistent Post Surgical Pain, run by Brigham and Women's Hospital.
Trial summary
The aim of the study is to investigate whether pre-operative dysregulated systemic lipid mediator pathways are associated with increased risk for the development of persistent post surgical pain. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Patients Scheduled for Thoracic Surgery/Esophagectomy Will be Enrolled, Persistent Post Surgical Pain
- What is being tested?
- fractionated marine lipid concentrate derived from anchovy and sardine oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Start not givento 1 Jul 2019
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- scheduled to undergo esophagectomy at BWH
- 18-80 years old
Who cannot join
- pre-existing chronic pain
- current opioid use
- current treatment with corticosteroids
- evidence of active infection
- chronic liver disease
- end-stage renal disease (CKD-5)
Show all 13Show fewer
- chronic inflammatory disorders
- recent major surgery or illness within 30 days
- use of immunosuppressive medication
- history of organ transplant
- pregnancy or plans to become pregnant
- lactating
- allergies to fish or fish oil
Trial locations and contacts
No sites are listed yet.
About this study
The aim of the study is to investigate whether pre-operative dysregulated systemic lipid mediator pathways are associated with increased risk for the development of persistent post surgical pain. In addition we will investigate whether treatment with an over the counter dietary supplement containing a fractionated marine lipid derivative from anchovy and sardine oil prevents the development of chronic pain after surgery.
- Conditions
- Patients Scheduled for Thoracic Surgery/Esophagectomy Will be Enrolled, Persistent Post Surgical Pain
- Being tested
- fractionated marine lipid concentrate derived from anchovy and sardine oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fractionated marine lipid concentrate derived from anchovy and sardine oilDietary supplement
Patients will be randomized to receive perioperative treatment versus placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: fractionated marine lipid concentrate derived from anchovy and sardine oil |
| Treatment | Experimental | Not described Receives: Dietary Supplement: fractionated marine lipid concentrate derived from anchovy and sardine oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale (0=no pain; 10=worst imaginable pain) at 3 months after surgery
Persistent pain after thoracic surgery
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 posted29 Mar 2017
- Primary completion1 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Scheduled for Thoracic Surgery/Esophagectomy Will be EnrolledStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mieke A. Soens, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03095157
- Sponsor's protocol ID
- 2017P000346
- Status last verified
- Mar 2017
- First submitted
- 16 Mar 2017
- Last updated
- 29 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Emerging Role of Resolvins in the Prevention of Chronic Pain After Thoracic Surgery
- ClinicalTrials.gov ID
- NCT03095157
- Acronym / sponsor ID
- 2017P000346
- Conditions
- Patients Scheduled for Thoracic Surgery/Esophagectomy Will be Enrolled, Persistent Post Surgical Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Primary completion
- 1 Jul 2019 (estimated)
- First posted
- 29 Mar 2017 (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 aim of the study is to investigate whether pre-operative dysregulated systemic lipid mediator pathways are associated with increased risk for the development of persistent post surgical pain. In addition we will investigate whether treatment with an over the counter dietary supplement containing a fractionated marine lipid derivative from anchovy and sardine oil prevents the development of chronic pain after surgery.
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 | Dietary Supplement: fractionated marine lipid concentrate derived from anchovy and sardine oil |
| Treatment | Experimental | Dietary Supplement: fractionated marine lipid concentrate derived from anchovy and sardine oil |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- scheduled to undergo esophagectomy at BWH
- 18-80 years old
Key exclusion criteria (13 listed)
- pre-existing chronic pain
- current opioid use
- current treatment with corticosteroids
- evidence of active infection
- chronic liver disease
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 |
|---|---|---|
| fractionated marine lipid concentrate derived from anchovy and sardine oilPatients will be randomized to receive perioperative treatment versus placebo | Dietary supplement | Placebo, Treatment |
Primary outcome
Numeric Rating Scale (0=no pain; 10=worst imaginable pain) at 3 months after surgery
Time frame: 3 months
Persistent pain after thoracic surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
A study testing fractionated marine lipid concentrate derived from anchovy and sardine oil in people with Patients Scheduled for Thoracic Surgery/Esophagectomy Will be Enrolled and Persistent Post Surgical Pain, run by Brigham and Women's Hospital.
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: status not confirmed, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mieke Soens, MD (617-732-6798, msoens@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating Scale (0=no pain; 10=worst imaginable pain) at 3 months after surgery (time frame: 3 months). 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 29 Mar 2017.