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

Chemotherapy-induced Peripheral Neuropathy Clinical Trial

— NOVIT1  

Official title:

Early Detection and Prevention of Neuropathy and Cognitive Impairment Following Treatment for Haematological Malignancies (the NOVIT Study)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04393363
• Other study ID #: N-20190068
• Status: Active, not recruiting
• Start date: August 14, 2020
• Est. completion date: December 31, 2030

Study information

• Verified date: January 2024
• Source: Aalborg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 31, 2030
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy-induced Peripheral Neuropathy
• Cognitive Dysfunction
• Hematologic Neoplasms
• Peripheral Nervous System Diseases

Locations

Country	Name	City	State
Denmark	Department of Haematology, Aalborg University Hospital	Aalborg

Sponsors (2)

Lead Sponsor	Collaborator
Aalborg University Hospital	Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Change in The National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in VagusTM Test	A measurement for autonomic neuropathy by evaluation of heart rate in different positions	0-12 months
Secondary	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
Secondary	Change in vitamin B12-level in blood test	Measurement of deficiency/functional deficiency	0-12 months