CancerDEX-PALNCT07885475

Dexmedetomidine for Refractory Pain in Palliative Cancer Patients

An observational study of Cancer and Palliative Care, Patient Care, run by St. Olavs Hospital at 4 sites in Norway.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Trial summary

The goal of this study is to find out whether the medication dexmedetomidine can be a safe and effective additional treatment for cancer patients whose pain is not well controlled by standard pain medicines (such as opioids). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cancer, Palliative Care, Patient Care, Pain Management
How many people: 30 participants
Where: 4 sitesNorway
Study dates: 10 Apr 2026to Dec 2027
Phase: Observational

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

Study population: Palliative cancer patients about to undergo treatment with dexmedetomidine due to uncontrolled cancer pain.

Who may be able to join

Adult cancer patients (>18 years), not receiving curative treatment
Treated with parenteral opioids for cancer-related pain
Indication to start dexmedetomidine treatment due to uncontrolled background pain (NRS > 4 in a numeric rating scale (NRS 0-10)) despite hospitalization and standard pain management.

Who cannot join

Dexmedetomidine hypersensitivity
Hypotension (systolic blood pressure (BP) < 90)
Bradycardia (heart rate (HR) < 50)
Serious heart disease or AV block grade 2 or 3 if no pacemaker.
Severe liver failure (e.g. Child-Pugh-C or similar)
Acute cerebrovascular disease
Neuraxial pain management
Patients unable to comply with trial procedures

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ragnhild H Habberstad, M.D p.HD contact

+47 72825840

ragnhild.hansdatter.habberstad@stolav.no

Morten Thronæs, M.D pHD contact

+47 72825840

Morten.Thrones@stolav.no

Norway4 sites, 4 recruiting

Drammen Hospital
Drammen
Kristin M Husby, MD pHD, +47 32803030, Kristin.Moksnes.Husby@vestreviken.no
Not yet recruiting
Oslo University Hospital
Oslo
Olav E Yri, MD pHD, +47 22934000, olavy@ous-hf.no
Not yet recruiting
Univsersity Hospital of North Norway
Tromsø
Sigve Andersen, MD pHD, + 47 72626000, sigve.andersen@unn.no
Not yet recruiting
St.Olavs Hospital, Trondheim Univsersity Hospital
Trondheim
Ragnhild Habberstad, MD pHD, +47 72825840, ragnhild.hansdatter.habberstad@stolav.no
Recruiting

Other trials in Norway

About this study

The study includes 30 palliative care patients who still have significant pain despite standard pain treatment. All participants will receive dexmedetomidine, and outcomes related to efficacy and safety will be systematically observed.

Read the detailed description

The overall aim of this study is to investigate whether add-on dexmedetomidine, a selective alpha-2 adrenergic receptor agonist, is effective and safe in the treatment of refractory cancer pain. The study is designed as a prospective observational study, including 30 palliative cancer patients with uncontrolled cancer pain despite the use of opioids, about to undergo treatment with dexmedetomidine.

Dexmedetomidine is used in intensive care units as a sedative, anxiolytic, and analgesic-sparing drug. It represents a promising treatment option in advanced cancer patients with uncontrolled pain. Off-label use of dexmedetomidine for refractory cancer pain is conducted in Norwegian hospitals. However, the evidence base for the use of dexmedetomidine in this population is limited. Available studies are mostly small and retrospective, with a high risk of bias. To assure patient safety and to establish a better body of evidence, a prospective observational trial on the use of dexmedetomidine in palliative cancer care is needed.

Conditions: Cancer, Palliative Care, Patient Care, Pain Management, Dexmedetomidine Analgesia, Opioid
Keywords: palliative care, dexmedetomidine, refractory cancer pain, opioid
Medical subject headings: Neoplasms, Agnosia, Cancer Pain

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain intensity
Change in worst pain intensity past 24 hours (NRS 0-10) on day five.
Measured: 5 days

Secondary outcomes (2)

Dexmedetomidine dose
Dexmedetomidine dose at start, day 5 and during follow-up.
Measured: Baseline starting dose, dose day 5, dose alterations during the follow-up period as long at treated with dexmedetomidine. Maximum 6 months.
Adverse events
Adverse events (AE) registrations during the study period.
Measured: Through study completion, as long as treated with dexmedetomidine Maximum 6 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Apr 2026Dec 2027

First posted21 Oct 2026
Study start10 Apr 2026
Primary completionOct 2027 (estimated)
Study completionDec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for 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: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07885475
Sponsor's protocol ID: 939758
Acronym: DEX-PAL
Status last verified: Oct 2026
First submitted: 15 Jun 2026
Last updated: 21 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided