Early Detection of Neuropathy and Cognitive Impairment Following Treatment for Haematological Malignancies

  • STATUS
    Recruiting
  • End date
    Dec 31, 2030
  • participants needed
    20
  • sponsor
    Aalborg University Hospital
Updated on 25 January 2021
cancer
vincristine
lenalidomide
bortezomib
peripheral neuropathy

Summary

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.

Description

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.

Details
Condition Chemotherapy Induced Peripheral Neuropathy
Clinical Study IdentifierNCT04393363
SponsorAalborg University Hospital
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Men and women, age 18 years
Scheduled for treatment with Vincristine (R-CHOP, CHOP, R-CHOEP, CHOEP, R-CVP, CVP or simi-lar), Bortezomib (VCD, MPV, VRD or similar) or Lenalidomide (VRD, len-dex or similar) regardless of type of haematological malignancy
Not started chemotherapy treatment before enrollment (pretreatment with steroids is allowed)
Associated to Department of Haematology, Aalborg University Hospital during the project period
Signed informed consent form
Able to read and speak Danish

Exclusion Criteria

Known vitamin B12 deficiency and treated with either oral or intramuscular vitamin B12 within the last year
Known neural damage or disease in the neural system (e.g. MS, Guillain-Barre etc.)
Known severe skin disease
Pregnancy or breastfeeding
Inability to understand or comply with instructions
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