Clinical trial NCT02654691: Chronic Neuropathy Following Chemotherapy
Official title: DOLORISK: Understanding Risk Factors and Determinants for Neuropathic Pain - Chronic Neuropathy Following Chemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Nervous System Diseases
Chronic Pain
Keywords: Chemotherapy
Lead sponsor: Danish Pain Research Center
Sponsor class: OTHER
Collaborators: name: University of Oxford
name: Imperial College London
name: University of Dundee
name: Mentis Cura
name: Institut National de la Santé Et de la Recherche Médicale, France
name: University of Kiel
name: Lund University
name: Technion, Israel Institute of Technology
name: University Ghent
name: Neuroscience Technologies S.L.P
First posted: 2016-01-13
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who underwent chemotherapy for a high-risk mamma-cancer and a high-risk colon-cancer from the period of 2011-2012 and who participated in a prospective questionnaire study (Ventzel et al. 2015).

Brief summary: This is a clinical study which is a follow-up of a previous prospective questionnaire study. All patients who previously participated in the study will receive a new questionnaire and will be invited for a clinical examination.

Detailed description: This is a clinical study which is a follow-up of a previous prospective questionnaire study. All patients who previously participated in the study will receive a new questionnaire and will be invited for a clinical examination. This is a collaboration and part of the data will be combined with other data in this collaboration

Eligibility criteria: Inclusion Criteria:

* all patients who have participated in a prospective questionnaire study

Exclusion Criteria:

* Not able to visit in person.

Primary outcomes:
measure: Chemotherapy-induced Peripheral Neuropathy
timeFrame: 5-year follow-up
measure: Chemotherapy-induced Neuropathic Pain
timeFrame: 5-year follow-up
Secondary outcomes:
measure: Sensory Abnormalities After Chemotherapy Assessed With Quantitative Sensory Testing (QST).
timeFrame: 5-year follow-up
measure: Neuronal Excitability Changes After Chemotherapy Assessed With Threshold Tracking: Sensory
timeFrame: 5-year follow-up
measure: Anxiety and Depression Using the Patient Reported Outcomes Measurement Information System (PROMIS).
timeFrame: 5-year follow-up
measure: Anxiety and Depression Using the Hospital Anxiety and Depression Scale (HADS).
timeFrame: 5-year follow-up
measure: Fatigue Using the Patient Reported Outcomes Measurement Information System (PROMIS).
timeFrame: 5-year follow-up
measure: Quality of Life Using EuroQol (EQ-5D).
timeFrame: 5-year follow-up
measure: Personality Using the 10-item Personality Inventory (TIPI).
timeFrame: 5-year follow-up
measure: Personality Using the International Personality Item Pool (IPIP).
timeFrame: 5-year follow-up
measure: Pain Catastrophizing Using the Pain Catastrophizing Scale(PCS).
timeFrame: 5-year follow-up
measure: Morphology of Small Fibers in Cornea After Chemotherapy by Corneal Confocal Microscopy (CCM).
timeFrame: 5-year follow-up
measure: Blood Samples DNA
timeFrame: 5-year follow-up
measure: Pain Interference by Patient Reported Outcomes Measurement Information System (PROMIS).
timeFrame: 5-year follow-up
measure: Pain Descriptors by Douleur Neuropathique 4 (DN4).
timeFrame: 5-Year follow-up
measure: Pain Descriptors by Neuropathic Pain Symptom Inventory (NPSI).
timeFrame: 5-Year follow-up
measure: Neuropathy Using the Toronto Clinical Scoring System (TCSS).
timeFrame: 5-year follow-up
measure: Neuropathy Using the Total Neuropathy Score.
timeFrame: 5-year follow-up
measure: Neuropathy Using the Michigan Neuropathy Screening Instrument (MNSI).
timeFrame: 5-year follow-up
measure: Neuronal Excitability Changes After Chemotherapy Assessed With Threshold Tracking: Motor
timeFrame: 5-year follow-up
measure: Neuronal Excitability Changes After Chemotherapy Assessed With Threshold Tracking: Sensory
timeFrame: 5-year follow-up
measure: Neuronal Excitability Changes After Chemotherapy Assessed With Threshold Tracking: Motor
timeFrame: 5-year follow-up
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Danish Pain Research Center, Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital and Aarhus University
name: Kristine J Bennedsgaard, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ventzel L, Jensen AB, Jensen AR, Jensen TS, Finnerup NB. Chemotherapy-induced pain and neuropathy: a prospective study in patients treated with adjuvant oxaliplatin or docetaxel. Pain. 2016 Mar;157(3):560-568. doi: 10.1097/j.pain.0000000000000404.
citation: Tesfaye S, Boulton AJ, Dyck PJ, Freeman R, Horowitz M, Kempler P, Lauria G, Malik RA, Spallone V, Vinik A, Bernardi L, Valensi P; Toronto Diabetic Neuropathy Expert Group. Diabetic neuropathies: update on definitions, diagnostic criteria, estimation of severity, and treatments. Diabetes Care. 2010 Oct;33(10):2285-93. doi: 10.2337/dc10-1303.