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

NCT04393363 | Active Not Recruiting

• 1 other identifier: N-20190068
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapy-induced Peripheral Neuropathy

Keywords

vincristine; bortezomib; lenalidomide; Assessment of nerve fiber excitability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change in nerve excitability assessed by Perception Threshold Tracking

  0-12 months

• Change in The National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)

  0-12 months

• Change in the Total Neuropathy Score-Clinical

  0-12 months

• Change in Quality of Life (The total FACT/GOG-Ntx-score)

  0-12 months

• Change in Montreal Cognitive Assessment (MoCA)

  0-12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aalborg University Hospital: lead
• Aalborg University: collaborator

Study Sites (1)

Department of Haematology, Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Related Publications (1)

• 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.

  PMID: 40011273 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood/plasma

Study Officials

• Marianne T Severinsen, MD, PhD

  Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, Head of Research, Ass. Professor

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: May 19, 2020
• Study Start: August 14, 2020
• Primary Completion: August 30, 2023
• Study Completion (Estimated): December 31, 2030
• Last Updated: January 31, 2024

Record last verified: 2024-01

Locations

DK (1)