Clinical trial · Observational
Early Detection of Neuropathy and Cognitive Impairment Following Treatment for Haematological Malignancies
Early Detection and Prevention of Neuropathy and Cognitive Impairment Following Treatment for Haematological Malignancies (the NOVIT Study)
NCT04393363CI-TRIAL-00073465NOVIT1active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy-induced Peripheral Neuropathy | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Change in neuropathy assessed by change in the neurotoxicity (ntx)-subscale of the FACT/GOG-Ntx-13-Score
- timeFrame
- 0-12 months
- description
- 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
Secondary outcomes (9)
- measure
- Change in nerve excitability assessed by Perception Threshold Tracking
- timeFrame
- 0-12 months
- description
- Assessment of nerve excitability in both large and small fiber nerves measured by two different electrodes.
- measure
- Change in The National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)
- timeFrame
- 0-12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMaksten 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