Clinical trial · Observational
Pain Phenotyping of Patients With Bone Cancer Pain
NCT03908853CI-TRIAL-00050409BonemetPAINunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study aims to describe and quantify pain related to metastatic bone disease. The study will include 50 subjects with disseminated breast cancer and 20 healthy subjects. The pain will be described and quantified through (1) pain specific questionnaires, (2) quantitative sensory testing that assess sensory changes to cold, heat and mechanical stimulation of the skin overlying the metastatic site, and (3) conditioned pain modulation that investigates impairment of the endogenous inhibitory pain pathway in humans.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Metastases | — | UNRESOLVED | — |
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Patients
- description
- Subjects with painful bone metastases caused by primary breast cancer.
- label
- Controls
- description
- Gender and age matched healthy volunteers.
Primary outcomes (2)
- measure
- Conditioned pain modulation (CPM) determined by cuff pressure algometry
- timeFrame
- 1 day
- description
- CPM will be determined by placing two inflatable cuffs around the lower legs; one providing a test stimulus and the other a conditioning stimulus. First, the pressure pain detection and tolerance thresholds (kPa) are determined on each lower leg using an increasing pressure of 1 kPa/s; next a constant conditioning stimulus is applied to the dominant lower leg and 10 seconds later the pain pressure detection and tolerance threshold (kPa) are simultaneously determined on the non-dominant leg. The CPM effect is assessed as the percent difference between the measured thresholds on the non-dominant lower leg.
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Woman * Primary breast cancer * Bone metastases * Competent Exclusion Criteria: * Not fluent in spoken Danish * Chemotherapy or radiation within the last 3 months * Other chronic pain disease that may affect the quantitative sensory testing or conditioned pain modulation * Alcohol or medicine abuse * Pregnancy
References
Publications (12)
- BACKGROUNDStromgren AS, Sjogren P, Goldschmidt D, Petersen MA, Pedersen L, Groenvold M. Symptom priority and course of symptomatology in specialized palliative care. J Pain Symptom Manage. 2006 Mar;31(3):199-206. doi: 10.1016/j.jpainsymman.2005.07.007. PMID 16563314
- BACKGROUNDBanning A, Sjogren P, Henriksen H. Treatment outcome in a multidisciplinary cancer pain clinic. Pain. 1991 Nov;47(2):129-134. doi: 10.1016/0304-3959(91)90195-4. No abstract available. PMID 1762805
- BACKGROUNDMercadante S. Managing difficult pain conditions in the cancer patient. Curr Pain Headache Rep. 2014 Feb;18(2):395. doi: 10.1007/s11916-013-0395-y. PMID 24407750
- BACKGROUNDLaird BJ, Walley J, Murray GD, Clausen E, Colvin LA, Fallon MT. Characterization of cancer-induced bone pain: an exploratory study. Support Care Cancer. 2011 Sep;19(9):1393-401. doi: 10.1007/s00520-010-0961-3. Epub 2010 Aug 1. PMID 20680354
- BACKGROUNDHald A, Nedergaard S, Hansen RR, Ding M, Heegaard AM. Differential activation of spinal cord glial cells in murine models of neuropathic and cancer pain. Eur J Pain. 2009 Feb;13(2):138-45. doi: 10.1016/j.ejpain.2008.03.014. Epub 2008 May 21. PMID 18499488
- BACKGROUNDBloom AP, Jimenez-Andrade JM, Taylor RN, Castaneda-Corral G, Kaczmarska MJ, Freeman KT, Coughlin KA, Ghilardi JR, Kuskowski MA, Mantyh PW. Breast cancer-induced bone remodeling, skeletal pain, and sprouting of sensory nerve fibers. J Pain. 2011 Jun;12(6):698-711. doi: 10.1016/j.jpain.2010.12.016. Epub 2011 Apr 15. PMID 21497141
- BACKGROUNDDonovan-Rodriguez T, Urch CE, Dickenson AH. Evidence of a role for descending serotonergic facilitation in a rat model of cancer-induced bone pain. Neurosci Lett. 2006 Jan 30;393(2-3):237-42. doi: 10.1016/j.neulet.2005.09.073. Epub 2005 Oct 25.