Chronic Neuropathy Following Chemotherapy

NCT02654691 | Completed Results

• 1 other identifier: CIPN-2015
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Nervous System Diseases; Chronic Pain

Keywords

Chemotherapy

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (20)

• Sensory Abnormalities After Chemotherapy Assessed With Quantitative Sensory Testing (QST).

  5-year follow-up

• Neuronal Excitability Changes After Chemotherapy Assessed With Threshold Tracking: Sensory

  5-year follow-up

• Anxiety and Depression Using the Patient Reported Outcomes Measurement Information System (PROMIS).

  5-year follow-up

• Anxiety and Depression Using the Hospital Anxiety and Depression Scale (HADS).

  5-year follow-up

• Fatigue Using the Patient Reported Outcomes Measurement Information System (PROMIS).

  5-year follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• all patients who have participated in a prospective questionnaire study

You may not qualify if:

• Not able to visit in person.

Sponsors & Collaborators

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

Study Sites (1)

Danish Pain Research Center, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Related Publications (2)

• 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.

  PMID: 26529271 BACKGROUND

• 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.

  PMID: 20876709 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Chronic Pain

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Nanna Finnerup
• Organization: Aarhus University

finnerup@clin.au.dk

0045 78463382

Study Officials

• Kristine J Bennedsgaard, MD

  Aarhus University Hospital and Aarhus University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2015
• First Posted: January 13, 2016
• Study Start: June 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: July 1, 2019
• Last Updated: February 25, 2021
• Results First Posted: February 25, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)