Peripheral Nervous System DiseasesDOLORISKCIPNNCT02654691
Chronic Neuropathy Following Chemotherapy
An observational study of Peripheral Nervous System Diseases and Chronic Pain, run by Danish Pain Research Center at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Nervous System Diseases, Chronic Pain
- How many people
- 63 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2016to 1 Jul 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: 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).
Who may be able to join
- all patients who have participated in a prospective questionnaire study
Who cannot join
- Not able to visit in person.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Danish Pain Research Center, Aarhus University Hospital
Aarhus, 8000
About this study
Official title: DOLORISK: Understanding Risk Factors and Determinants for Neuropathic Pain - Chronic Neuropathy Following Chemotherapy
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.
Read the 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
- Conditions
- Peripheral Nervous System Diseases, Chronic Pain
- Keywords
- Chemotherapy
- Medical subject headings
- Peripheral Nervous System Diseases, Chronic Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Chemotherapy-induced Peripheral Neuropathy
For case definition of neuropathy, The Toronto classification (Tesfaye et al. 2010) will be used.
Numbers indicate confirmed neuropathy.
Measured: 5-year follow-up
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).
Measured: 5-year follow-up
Secondary outcomes (20)
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).
Measured: 5-year follow-up
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).
Measured: 5-year follow-up
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
Measured: 5-year follow-up
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.
Measured: 5-year follow-up
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
Measured: 5-year follow-up
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
Measured: 5-year follow-up
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
Measured: 5-year follow-up
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.
Measured: 5-year follow-up
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.
Measured: 5-year follow-up
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).
Measured: 5-year follow-up
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.
Measured: 5-year follow-up
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
Measured: 5-year follow-up
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.
Measured: 5-Year follow-up
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.
Measured: 5-Year follow-up
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.
Measured: 5-year follow-up
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.
Measured: 5-year follow-up
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.
Measured: 5-year follow-up
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).
Measured: 5-year follow-up
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).
Measured: 5-year follow-up
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).
Measured: 5-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2016 (estimated)
- Study startJun 2016
- Primary completionApr 2017
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peripheral Nervous System DiseasesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Pain Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford, Imperial College London, University of Dundee, Mentis Cura, Institut National de la Santé Et de la Recherche Médicale, France, University of Kiel, Lund University, Technion, Israel Institute of Technology, University Ghent, Neuroscience Technologies S.L.P
- Responsible party
- Sponsor
- Investigators
- Kristine J Bennedsgaard, MD, Principal investigator, Aarhus University Hospital and Aarhus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02654691
- Sponsor's protocol ID
- CIPN-2015
- Acronym
- DOLORISKCIPN
- Status last verified
- Feb 2021
- First submitted
- 22 Dec 2015
- Last updated
- 25 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Data is shared among collaborators (DOLORisk consortium)
Publications
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.
PubMed 26529271Tesfaye 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.
PubMed 20876709
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DOLORISK: Understanding Risk Factors and Determinants for Neuropathic Pain - Chronic Neuropathy Following Chemotherapy
- ClinicalTrials.gov ID
- NCT02654691
- Acronym / sponsor ID
- DOLORISKCIPN / CIPN-2015
- Conditions
- Peripheral Nervous System Diseases, Chronic Pain
- Keywords
- Chemotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Danish Pain Research CenterUniversity, hospital or other
- Collaborators
- University of Oxford, Imperial College London, University of Dundee, Mentis Cura, Institut National de la Santé Et de la Recherche Médicale, France, University of Kiel, Lund University, Technion, Israel Institute of Technology, University Ghent, Neuroscience Technologies S.L.P
- Study start
- Jun 2016
- Primary completion
- Apr 2017 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 13 Jan 2016 (estimated)
- Results
- Posted 25 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- all patients who have participated in a prospective questionnaire study
Key exclusion criteria (1 listed)
- Not able to visit in person.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Chemotherapy-induced Peripheral Neuropathy
Time frame: 5-year follow-up
For case definition of neuropathy, The Toronto classification (Tesfaye et al. 2010) will be used. Numbers indicate confirmed neuropathy.
Chemotherapy-induced Neuropathic Pain
Time frame: 5-year follow-up
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).
20 secondary outcomes
Sensory Abnormalities After Chemotherapy Assessed With Quantitative Sensory Testing (QST).
Time frame: 5-year follow-up
Neuronal Excitability Changes After Chemotherapy Assessed With Threshold Tracking: Sensory
Time frame: 5-year follow-up
Anxiety and Depression Using the Patient Reported Outcomes Measurement Information System (PROMIS).
Time frame: 5-year follow-up
Anxiety and Depression Using the Hospital Anxiety and Depression Scale (HADS).
Time frame: 5-year follow-up
Fatigue Using the Patient Reported Outcomes Measurement Information System (PROMIS).
Time frame: 5-year follow-up
Quality of Life Using EuroQol (EQ-5D).
Time frame: 5-year follow-up
Personality Using the 10-item Personality Inventory (TIPI).
Time frame: 5-year follow-up
Personality Using the International Personality Item Pool (IPIP).
Time frame: 5-year follow-up
Pain Catastrophizing Using the Pain Catastrophizing Scale(PCS).
Time frame: 5-year follow-up
Morphology of Small Fibers in Cornea After Chemotherapy by Corneal Confocal Microscopy (CCM).
Time frame: 5-year follow-up
Blood Samples DNA
Time frame: 5-year follow-up
Pain Interference by Patient Reported Outcomes Measurement Information System (PROMIS).
Time frame: 5-year follow-up
Pain Descriptors by Douleur Neuropathique 4 (DN4).
Time frame: 5-Year follow-up
Pain Descriptors by Neuropathic Pain Symptom Inventory (NPSI).
Time frame: 5-Year follow-up
Neuropathy Using the Toronto Clinical Scoring System (TCSS).
Time frame: 5-year follow-up
Neuropathy Using the Total Neuropathy Score.
Time frame: 5-year follow-up
Neuropathy Using the Michigan Neuropathy Screening Instrument (MNSI).
Time frame: 5-year follow-up
Neuronal Excitability Changes After Chemotherapy Assessed With Threshold Tracking: Motor
Time frame: 5-year follow-up
Neuronal Excitability Changes After Chemotherapy Assessed With Threshold Tracking: Sensory
Time frame: 5-year follow-up
Neuronal Excitability Changes After Chemotherapy Assessed With Threshold Tracking: Motor
Time frame: 5-year follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26529271Ventzel 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.
- Background: PubMed 20876709Tesfaye 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.
- Individual participant dataSharing planned: No. Data is shared among collaborators (DOLORisk consortium)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristine J Bennedsgaard, MD principal investigator
Aarhus University Hospital and Aarhus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Nervous System Diseases and Chronic Pain, run by Danish Pain Research Center at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chemotherapy-induced Peripheral Neuropathy (time frame: 5-year follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02654691, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2021.