Early Detection of Neuropathy and Cognitive Impairment Following Treatment for Haematological Malignancies (NOVIT1)

Aalborg University Hospital

Status: Active, not recruiting

Conditions: Chemotherapy-induced Peripheral Neuropathy

Study type: Observational

Funder types: Other

Identifiers

NCT04393363

N-20190068

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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