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| Name | Class |
|---|---|
| Aalborg University | OTHER |
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Chemotherapy-induced peripheral neuropathy (CIPN) is a common, but not well understood complication to treatment with chemotherapy. In this study the investigators will investigate a novel method for early detection of CIPN and compare it to other methods in patients treated for haematological cancers.
Haematological malignancies can be treated with chemotherapy if the patient tolerates the treatment. However, many patients develop complications during treatment including chemotherapy-induced peripheral neuropathy (CIPN) and/or impaired memory. Even though it is a well-known complication, no gold standard for CIPN assessment is known. Besides chemotherapy reduction or cessation, there is so far no sufficient prevention or treatment, therefore early detection and intervention is crucial.
The main purpose of this study is to find a reliable test for chemotherapy-induced peripheral neuropathy (CIPN) in order to predict early signs of CIPN. All included patients has to be scheduled for treatment with vincristine, bortezomib or lenalidomide regardless of haematological malignancy. Neuropathy and cognitive impairment will be tested at baseline (prior to treatment with chemotherapy), before each treatment course, 1 month after treatment and finally 1 year after onset of chemotherapy. CIPN will be examined by different methods: Clinician-based assessment, objective neurophysiological parameters and patient-reported outcome. A novel test using Perception Threshold Tracking (PTT), developed at Aalborg University, is included in the study. The test investigates the nerve excitability in both large and small fiber nerve fibers using two different electrodes. Blood samples will be collected, stored, and analyzed for deficiencies correlated to neuropathy.
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| Measure | Description | Time Frame |
|---|---|---|
| Change in neuropathy assessed by change in the neurotoxicity (ntx)-subscale of the FACT/GOG-Ntx-13-Score | A patient questionnaire with focus on Quality of Life and neuropathy. Range 0-52 with higher score meaning better Quality of Life (less neuropathy). Neuropathy will be defined as a 10 % reduction in the Ntx-score | 0-12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in nerve excitability assessed by Perception Threshold Tracking | Assessment of nerve excitability in both large and small fiber nerves measured by two different electrodes. | 0-12 months |
| Change in The National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) |
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Inclusion Criteria:
Exclusion Criteria:
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Haematological patients scheduled for (but not started) treatment with vincristine, bortezomib or lenalidomid regardless of type of haematological malignancy.
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| Name | Affiliation | Role |
|---|---|---|
| Marianne T Severinsen, MD, PhD | Aalborg University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Haematology, Aalborg University Hospital | Aalborg | 9000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40011273 | Derived | Maksten EF, Morch CD, Jakobsen LH, Kragholm KH, Blindum PF, Simonsen MR, Ejskjaer N, Dybkaer K, Gregersen H, Madsen J, El-Galaly TC, Severinsen MT. The course of chemotherapy-induced peripheral neuropathy (CIPN) in hematological patients treated with vincristine, bortezomib, or lenalidomide: the NOVIT study. Support Care Cancer. 2025 Feb 26;33(3):225. doi: 10.1007/s00520-025-09282-3. |
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Blood/plasma
A grading scale 1-5 (with 5 as the worst) for neuropathy evaluated by the medical doctor based on the patients' symptoms. |
| 0-12 months |
| Change in the Total Neuropathy Score-Clinical | A score based on clinical evaluation (pin and vibration sensibility, strength and reflexes) and subjective reports from the patient (sensory, motor and autonomic symptoms). The score grades from 0-28 with 28 at worst. | 0-12 months |
| Change in Quality of Life (The total FACT/GOG-Ntx-score) | A patient questionnaire with focus on Quality of Life and neuropathy. This part will focus on Quality of Life. Score range from 0-160 with higher score meaning higher Quality of Life | 0-12 months |
| Change in Montreal Cognitive Assessment (MoCA) | A quick and easy method to assess mild cognitive disturbance based on following parameters: Awareness, concentration, executive function, memory, abstract thinking, calculating abilities and orientation. The score is 0-30, score > 26 is normal (without cognitive disturbance). | 0-12 months |
| Change in the score for FACT/GOG-cog | A patient questionnaire used to assess cognitive function. The score is measured from 0-132 with higher score meaning better Quality of Life | 0-12 months |
| Change in VagusTM Test | A measurement for autonomic neuropathy by evaluation of heart rate in different positions | 0-12 months |
| Change in Bioimpendance | Measurement of body composition in order to investigate loss of muscle mass, which can influence motor function and imitate or mask motor neuropathy | 0-12 months |
| Change in vitamin B12-level in blood test | Measurement of deficiency/functional deficiency | 0-12 months |