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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in Denmark

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

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.

  1. 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

  2. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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.

  1. First posted13 Jan 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionApr 2017
  4. Study completion1 Jul 2019

Resources

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)
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
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 26529271
  • 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.

    PubMed 20876709

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.

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