Refractory PainPhase 2/3NCT03936205
Dexmedetomidine Addition to Morphine in Patients With Metastatic Cancer
A Phase 2/3 study testing Dexmedetomidine in people with Refractory Pain and Metastatic Cancer, run by Hotel Dieu de France Hospital.
Trial summary
Pain is a common symptom in patients nearing the end of life. Its prevalence varies between 30 and 75%. Nowadays, morphine is the most used molecule as first line treatment of moderate to severe pain. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Refractory Pain, Metastatic Cancer
- What is being tested?
- Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Oct 2017
- Phase
- Phase 2/3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any painful patient with metastatic cancer
- Whatever type of pain: nociceptive, neuropathic, or mixed
- Age > 18 and <75 years
- Patient under analgesic Tier III treatment: with moderate to severe pain and not relieved by non-opioid conventional treatment
- Patient cooperating capable of responding to the pain assessment by providing a number from 0 to 10 at the VAS
- Patient providing his explicit consent to participate in the study before inclusion (regardless of his inclusion in C or D Group)
- Patients with systolic blood pressure (SBP) ≥ 100 mmHg and a diastolic blood pressure (DBP) ≥ 50 mmHg
- Patients with a heart rate ≥ 50/min
Who cannot join
- Patient refusal to participate in the study or patient unable to give consent
- Age <18 or > 75 years
- Comatose uncooperative patient unable to respond to the assessment of pain by VAS
- Hypotensive patients with SBP < 100 mmHg and DBP < 60 mmHg or bradycardic with a heart rate < 50/min
- Patient with a heart rhythm disorder, or a disorder of the atrial-ventricular conduction
- Patients under beta-blocker
Show all 10Show fewer
- Patient with heart failure with an ejection fraction < 40%
- Patient suffering from allergy or previous intolerance to morphine or dexmedetomidine
- Patient with renal impairment with a creatinine clearance <3 0ml/min/1.73m2, or patient under hemodialysis or peritoneal dialysis.
- Patient with severe hepatic impairment with Child-Pugh score at C.
About this study
Official title: Does the Addition of Dexmedetomidine to Morphine Improve the Treatment of Pain in Patients With Metastatic Cancer? A Pilot Study
Pain is a common symptom in patients nearing the end of life. Its prevalence varies between 30 and 75%. Nowadays, morphine is the most used molecule as first line treatment of moderate to severe pain. However, this molecule, considering its side effects, may contribute in part to the discomfort of these patients and may increase the pre-existing agitation or delirium. There is therefore a need to find new agents, other than morphine, for pain control at the end of life, without the limitations that the morphine molecule has. The author reviewed the literature on the role of dexmedetomidine in the treatment of refractory symptoms in palliative care, including pain. It is an agonist of the adrenergic alpha 2 receptor having a sedative, analgesic action and a morphine sparing effect demonstrated postoperatively.
This study aims primarily at demonstrating that dexmedetomidine has a beneficial role in the treatment of pain in patients with metastatic cancer.
- Conditions
- Refractory Pain, Metastatic Cancer
- Being tested
- Dexmedetomidine
- Medical subject headings
- Pain, Intractable, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Patients allocated to this group receive a combination of Morphine and Dexmedetomidine
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Dexmedetomidine | Experimental | Not described Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
The visual analogue score is used to asses for pain score, the scale varies between 0 and 10 where 0 is no pain and 10 is worst pain encountered
Measured: 48 hours
Morphine consumption
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study startAug 2016
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory PainStudies 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 2/3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hotel Dieu de France Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicole Naccache, Hotel Dieu de France Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03936205
- Sponsor's protocol ID
- FM315
- Status last verified
- May 2019
- First submitted
- 1 May 2019
- Last updated
- 14 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Addition of Dexmedetomidine to Morphine Improve the Treatment of Pain in Patients With Metastatic Cancer? A Pilot Study
- ClinicalTrials.gov ID
- NCT03936205
- Acronym / sponsor ID
- FM315
- Conditions
- Refractory Pain, Metastatic Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Hotel Dieu de France HospitalUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 3 May 2019 (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.
Pain is a common symptom in patients nearing the end of life. Its prevalence varies between 30 and 75%. Nowadays, morphine is the most used molecule as first line treatment of moderate to severe pain. However, this molecule, considering its side effects, may contribute in part to the discomfort of these patients and may increase the pre-existing agitation or delirium. There is therefore a need to find new agents, other than morphine, for pain control at the end of life, without the limitations that the morphine molecule has. The author reviewed the literature on the role of dexmedetomidine in the treatment of refractory symptoms in palliative care, including pain. It is an agonist of the adrenergic alpha 2 receptor having a sedative, analgesic action and a morphine sparing effect demonstrated postoperatively.
This study aims primarily at demonstrating that dexmedetomidine has a beneficial role in the treatment of pain in patients with metastatic cancer.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Dexmedetomidine | Experimental | Drug: Dexmedetomidine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Any painful patient with metastatic cancer
- Whatever type of pain: nociceptive, neuropathic, or mixed
- Age > 18 and <75 years
- Patient under analgesic Tier III treatment: with moderate to severe pain and not relieved by non-opioid conventional treatment
- Patient cooperating capable of responding to the pain assessment by providing a number from 0 to 10 at the VAS
Key exclusion criteria (10 listed)
- Patient refusal to participate in the study or patient unable to give consent
- Age <18 or > 75 years
- Comatose uncooperative patient unable to respond to the assessment of pain by VAS
- Hypotensive patients with SBP < 100 mmHg and DBP < 60 mmHg or bradycardic with a heart rate < 50/min
- Patient with a heart rhythm disorder, or a disorder of the atrial-ventricular conduction
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 |
|---|---|---|
| DexmedetomidinePatients allocated to this group receive a combination of Morphine and Dexmedetomidine | Drug | Dexmedetomidine |
Primary outcome
Pain score
Time frame: 48 hours
The visual analogue score is used to asses for pain score, the scale varies between 0 and 10 where 0 is no pain and 10 is worst pain encountered
Morphine consumption
Time frame: 48 hours
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 14 May 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dexmedetomidine in people with Refractory Pain and Metastatic Cancer, run by Hotel Dieu de France 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 8 inclusion and 10 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 14 May 2019. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
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?
Pain score (time frame: 48 hours). The study lists 2 primary outcomes in all. 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 14 May 2019.