Clinical trial NCT04393363: Early Detection of Neuropathy and Cognitive Impairment Following Treatment for Haematological Malignancies
Official title: Early Detection and Prevention of Neuropathy and Cognitive Impairment Following Treatment for Haematological Malignancies (the NOVIT Study)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chemotherapy-induced Peripheral Neuropathy
Keywords: vincristine
bortezomib
lenalidomide
Assessment of nerve fiber excitability
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
Collaborators: name: Aalborg University
First posted: 2020-05-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Haematological patients scheduled for (but not started) treatment with vincristine, bortezomib or lenalidomid regardless of type of haematological malignancy.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in neuropathy assessed by change in the neurotoxicity (ntx)-subscale of the FACT/GOG-Ntx-13-Score
timeFrame: 0-12 months
Secondary outcomes:
measure: Change in nerve excitability assessed by Perception Threshold Tracking
timeFrame: 0-12 months
measure: Change in The National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)
timeFrame: 0-12 months
measure: Change in the Total Neuropathy Score-Clinical
timeFrame: 0-12 months
measure: Change in Quality of Life (The total FACT/GOG-Ntx-score)
timeFrame: 0-12 months
measure: Change in Montreal Cognitive Assessment (MoCA)
timeFrame: 0-12 months
measure: Change in the score for FACT/GOG-cog
timeFrame: 0-12 months
measure: Change in VagusTM Test
timeFrame: 0-12 months
measure: Change in Bioimpendance
timeFrame: 0-12 months
measure: Change in vitamin B12-level in blood test
timeFrame: 0-12 months
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Department of Haematology, Aalborg University Hospital
Study officials:
affiliation: Aalborg University Hospital
name: Marianne T Severinsen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: