Chronic Neuropathy Following Chemotherapy

Chronic Pain Clinical Trial

— DOLORISKCIPN  

Official title:

DOLORISK: Understanding Risk Factors and Determinants for Neuropathic Pain - Chronic Neuropathy Following Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02654691
• Other study ID #: CIPN-2015
• Status: Completed
• Start date: June 2016
• Est. completion date: July 1, 2019

Study information

• Verified date: February 2021
• Source: Danish Pain Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: July 1, 2019
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• all patients who have participated in a prospective questionnaire study

Exclusion Criteria:

• Not able to visit in person.

Related Conditions & MeSH terms

• Chronic Pain
• Nervous System Diseases
• Peripheral Nervous System Diseases

Locations

Country	Name	City	State
Denmark	Danish Pain Research Center, Aarhus University Hospital	Aarhus

Sponsors (11)

Lead Sponsor	Collaborator
Danish Pain Research Center	Imperial College London, Institut National de la Santé Et de la Recherche Médicale, France, Lund University, Mentis Cura, Neuroscience Technologies S.L.P, Technion, Israel Institute of Technology, University Ghent, University of Dundee, University of Kiel, University of Oxford

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

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. Review. Erratum in: Diabetes Care. 2010 Dec;33(12):2725. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chemotherapy-induced Peripheral Neuropathy	For case definition of neuropathy, The Toronto classification (Tesfaye et al. 2010) will be used.; Numbers indicate confirmed neuropathy.	5-year follow-up
Primary	Chemotherapy-induced Neuropathic Pain	Neuropathic pain grading system. Neuropathic pain was graded as "possible", "probable", or "definite" in accordance with the NeuPSIG grading system (Pascal M et al, Wellcome Open Research 2018).	5-year follow-up
Secondary	Sensory Abnormalities After Chemotherapy Assessed With Quantitative Sensory Testing (QST).	Modified German Research Network on Neuropathic Pain QST protocol assessed sensory abnormalities after chemotherapy assessed with quantitative sensory testing (QST).	5-year follow-up
Secondary	Neuronal Excitability Changes After Chemotherapy Assessed With Threshold Tracking: Sensory	Measurements found with threshold tracking. The most common sensory parameters assessed with sensory threshold tracking. Outcomes are extracted from the QTrack software. The relative refractory period (RRP) is the interval of time during which a second action potential can be initiated, refractoriness is change in threshold by a preceding simple impulse, and specifically at 2,5 ms. A shorten RRP makes the nerve more excitable and longer RRP less excitable (values see result 21 for refractoriness at 2.5 ms, superexcitability and subexcitability).	5-year follow-up
Secondary	Anxiety and Depression Using the Patient Reported Outcomes Measurement Information System (PROMIS).	Number of patients with mild, moderate or severe symptoms of depression or anxiety. Patient Reported Outcomes Measurement Information System (PROMIS) used to assess if the patients has a mild, moderat or severe symptoms of depression/anxiety. The scores from the questionnaires were converted into T-scores, which were used in grading the patients with mild , moderate or severe symptoms of depression or anxiety. A higher score indicates worse outcome. The minimum is no depression or anxiety and the maximum is severe depression or anxiey. Mild: T-score =55 and <65 Moderate: =65 and <75 Severe =75	5-year follow-up
Secondary	Anxiety and Depression Using the Hospital Anxiety and Depression Scale (HADS).	Mean scores using HADS of all participants. The score for anxiety and depression indicate the sum of 7 questions, each graded from 0 to 3. This means that a person can score between 0 (minimum) and 21 (maximum) for either anxiety or depression. Higher score meaning more symptoms of a possible depression or anxiety.	5-year follow-up
Secondary	Fatigue Using the Patient Reported Outcomes Measurement Information System (PROMIS).	Number of patients with mild, moderate or severe fatigue. PROMIS used to assess if the patients has a mild, moderat or severe symptoms of fatique. The scores from the questionnaires were converted into T-scores, which were used in grading the patients with mild, moderate or severe symptoms of fatigue. The minimum is no fatigue (T-score<50) and maximum severe fatigue (T-score =75). Higher scores mean a worse outcome. Mild: T-score =55 and <65 Moderate: =65 and <75 Severe =75	5-year follow-up
Secondary	Quality of Life Using EuroQol (EQ-5D).	The participants were asked to provided a score from 1-100 regarding quality of life on the Quality of life using EuroQol (EQ-5D). Minimum score 0, maximum score 100. A higher score indicate better outcome	5-year follow-up
Secondary	Personality Using the 10-item Personality Inventory (TIPI).	The Personality using the 10-item Personality Inventory (TIPI). TIPI is divided in 5 parameters Extraversion, Agreeableness, Conscientiousness, Emotional Stability, Openness. Minimum value is 2 and maximum value i 14. Higher scores indicate more Openness, Conscientiousness, Extraversion, Agreeableness and Emotional Stability	5-year follow-up
Secondary	Personality Using the International Personality Item Pool (IPIP).	Personality using the International Personality Item Pool (IPIP). A score were given from answering 10 questions regarding emotionel stability. Each question has 5 possible answers from 1 very inaccuate to 5 very accurate. Minimum combined value 10, maximum combined value 50. Higher score indicates worse outcome.	5-year follow-up
Secondary	Pain Catastrophizing Using the Pain Catastrophizing Scale(PCS).	Participants answered 13 question, which were each graded on a scale from 0-4 and combined to a sum scale.. The results are a mean score for all participants. The minimum value is 0 and the maximum value is 72. Higher scores indicate more Pain catastrophizing.	5-year follow-up
Secondary	Morphology of Small Fibers in Cornea After Chemotherapy by Corneal Confocal Microscopy (CCM).	The fibers in the cornea were scanned in one eye with the Heidelberg Retina Tomograph III laser-scanning confocal microscope (Heidelberg Engineering GmbH, Heidelberg, Germany). An automatic programme calculated the cornea nerve branches density (CNBD) and the cornea nerve fiber density (CNFD).	5-year follow-up
Secondary	Blood Samples DNA	Numbers indicate the number of participants, who had a blood sample collected. Potential gene associations in the development of painful neuropathy will be assessed together with other samples in the DOLORisk collaboration. The results here present the number of subjects who had a DNA blood sample taken.	5-year follow-up
Secondary	Pain Interference by Patient Reported Outcomes Measurement Information System (PROMIS).	Numbers given is patients with mild, moderate or severe pain interference of the patients with neuropathic pain. Patient Reported Outcomes Measurement Information System PROMIS used to assess if the patients has a mild, moderate or severe symptoms of pain interference. The scores from the questionnaires were converted into T-scores, which were used in grading the patients with mild, moderate or severe pain interference. The mimimum is no interference (T-score <50) and maximum is Severe (T-score=70)). Severe indicated more interference	5-year follow-up
Secondary	Pain Descriptors by Douleur Neuropathique 4 (DN4).	number of participants with a possible painful neuropathy with the Douleur Neuropathique 4DN4. Yes/no questions regarding symptoms and signs of neuropathic pain. In total the participants answered 7 questions. Each question is a yes or no and are combined to a sum score of number of positive answers. Minimum score is 0 and maximum score is 7. Higher score indicates larger probability of neuropathic Pain. A score of 3 or above indicates a possible painful neuropathy.	5-Year follow-up
Secondary	Pain Descriptors by Neuropathic Pain Symptom Inventory (NPSI).	The results were given on a scale from 0-100 for each of the 5 dimensions on the Neuropathic Pain Symptom Inventory (NPSI). Higher scores indicate worse symptoms. The sum score is the sum divided by 5. Minimum score is 0 and maximum score is 100.	5-Year follow-up
Secondary	Neuropathy Using the Toronto Clinical Scoring System (TCSS).	The Toronto Clinical Scoring System(TCSS), grades the severity of neuropathy and consists of 6 questions with the presence and description of symptoms and a 7-item clinical examination with reflexes in the lower extremities and a bedside sensory testing with pinprick, vibration, temperature, light touch and position of the 1st toe. The score ranges from 0-19. Higher score indicate worse outcome.	5-year follow-up
Secondary	Neuropathy Using the Total Neuropathy Score.	The TNScompact consists of 7 questions regarding sensory symptoms, motor symptoms, autonomic symptoms, pin sensation, vibrations sensitivity, strength and tendon reflexes graded from 0-4. The scores are combined and thus 0 being the lowest score possible and 28 being the highest score possible. A high score indicate severe neuropathy.	5-year follow-up
Secondary	Neuropathy Using the Michigan Neuropathy Screening Instrument (MNSI).	A cut-off = 4/13 abnormal responses has been suggested as the cut-off to define polyneuropathy.	5-year follow-up
Secondary	Neuronal Excitability Changes After Chemotherapy Assessed With Threshold Tracking: Motor	Measurements found with threshold tracking. The most common motor parameters assessed with threshold tracking. Outcomes are extracted from the QTrack software. The relative refractory period (RRP) is the interval of time during which a second action potential can be initiated, refractoriness is change in threshold by a preceding simple impulse, and specifically at 2,5 ms. A shorten RRP makes the nerve more excitable and longer RRP less excitable (values see result 22 for refractoriness at 2.5 ms, superexcitability and subexcitability).	5-year follow-up
Secondary	Neuronal Excitability Changes After Chemotherapy Assessed With Threshold Tracking: Sensory	Measurements found with threshold tracking. The most common sensory parameters assessed with sensory threshold tracking. Outcomes are extracted from the QTrack software. The relative refractory period (RRP) is the interval of time during which a second action potential can be initiated, refractoriness is change in threshold by a preceding simple impulse, and specifically at 2,5 ms. A shorten RRP makes the nerve more excitable and longer RRP less excitable (values see result 21 for refractoriness at 2.5 ms, superexcitability and subexcitability). Superexcitability and subexcitablity are measured in the recovery period. The recovery cycle is characterized by changes in axonal excitability following a supramaximal conditioning stimulus. The cycle includes a relative refractory period (at short inter-stimulus intervals), superexcitable period (when the threshold is reduced), and subexcitable period (when the nerve is less excitable).	5-year follow-up
Secondary	Neuronal Excitability Changes After Chemotherapy Assessed With Threshold Tracking: Motor	Measurements found with threshold tracking. The most common motor parameters assessed with threshold tracking. Outcomes are extracted from the QTrack software. The relative refractory period (RRP) is the interval of time during which a second action potential can be initiated, refractoriness is change in threshold by a preceding simple impulse, and specifically at 2,5 ms. A shorten (RRP) makes the nerve more excitable and longer RRP less excitable (values see result 22 for refractoriness at 2.5 ms, superexcitability and subexcitability). Superexcitability and subexcitablity are measured in the recovery period. The recovery cycle is characterized by changes in axonal excitability following a supramaximal conditioning stimulus. The cycle includes a relative refractory period (at short inter-stimulus intervals), superexcitable period (when the threshold is reduced), and subexcitable period (when the nerve is less excitable).	5-year follow-up