Clinical trial NCT03908853: Pain Phenotyping of Patients With Bone Cancer Pain
Official title: Pain Phenotyping of Patients With Bone Cancer Pain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pain
Bone Metastases
Metastatic Breast Cancer
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: The Novo Nordic Foundation
First posted: 2019-04-09
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 50 subjects with bone metastases caused by primary breast cancer and 20 healthy volunteers.

Brief summary: 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.

Detailed description: Cancer patients in palliative care point to pain as their most important and most feared symptom. Bone metastases are a common cause of cancer pain, and the patients are prone to transient severe pain exacerbations (breakthrough pain), which can occur spontaneously or be triggered by movement. Patients with bone metastases experience pain of such high intensity, that it affects not only physical activity, but also sleep, mood and social relations. This results in poor quality of life for the patients and poses an increasing clinical and socio-economical problem. The pain is difficult to treat and often requires high opioid doses which results in unacceptable adverse effects, and there is an unmet need of novel therapeutic options and treatment strategies.

Animal models of cancer-induced bone pain have suggested that pain arising from metastatic bone disease involve neuropathic and nociceptive pain mechanisms and, importantly, mechanisms that are specific to cancer-induced bone pain. Significant neuronal sprouting can occur at the metastatic site, and the inherent pain control system is found altered in animal models of cancer-induced bone pain; a system that can be exploited for treatment strategies and in the development of new analgesia. Yet, it is not known how the pre-clinical findings translate to patients.

Quantitative sensory testing is a psychophysical method that uses a battery of sensory stimuli with predetermined physical properties, thus allowing the capture and quantification of stimulus-evoked negative and positive sensory phenomena in humans. Conditioned pain modulation is a psychophysical experimental measure of the endogenous pain inhibitory pathway in humans, which can be used to detect an impairment of the descending inhibitory pain pathway.

This study aims to perform pain phenotyping of patients suffering from cancer-induced bone pain, through pain specific questionnaires, quantitative sensory testing and conditioned pain modulation.

Eligibility criteria: 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

Primary outcomes:
measure: Conditioned pain modulation (CPM) determined by cuff pressure algometry
timeFrame: 1 day
measure: Sensory mapping with thermorollers and brush
timeFrame: 1 day
Secondary outcomes:
measure: Mechanical pain threshold with PinPrick.
timeFrame: 1 day
measure: Wind up ratio with Pin Prick
timeFrame: 1 day
measure: Cuff pressure pain threshold and pressure pain tolerance determined by cuff pressure algometry
timeFrame: 1 day
measure: Temporal summation of pressure pain
timeFrame: 1 day
measure: Questionnaire - The Short Form Brief Pain Inventory
timeFrame: 1 day
measure: Questionnaire - PainDETECT
timeFrame: 1 day
measure: Questionnaire - The Breakthrough Pain Questionnaire
timeFrame: 1 day
measure: Questionnaire - Pain Catastrophizing Scale
timeFrame: 1 day
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Oncology, Rigshospitalet
city: Herlev
country: Denmark
facility: The Department of Oncology, Herlev Hospital
Study officials:
affiliation: University of Copenhagen
name: Anne-Marie Heegaard, PhD
role: PRINCIPAL_INVESTIGATOR
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