Chemotherapy-induced Peripheral NeuropathyNOVIT1NCT04393363
Early Detection of Neuropathy and Cognitive Impairment Following Treatment for Haematological Malignancies
An observational study of Chemotherapy-induced Peripheral Neuropathy, run by Aalborg University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 14 Aug 2020to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Haematological patients scheduled for (but not started) treatment with vincristine, bortezomib or lenalidomid regardless of type of haematological malignancy.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Haematology, Aalborg University Hospital
Aalborg, 9000
About this study
Official title: Early Detection and Prevention of Neuropathy and Cognitive Impairment Following Treatment for Haematological Malignancies (the NOVIT Study)
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.
Read the 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.
- Keywords
- vincristine, bortezomib, lenalidomide, Assessment of nerve fiber excitability
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0-12 months
Secondary outcomes (9)
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.
Measured: 0-12 months
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.
Measured: 0-12 months
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.
Measured: 0-12 months
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
Measured: 0-12 months
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).
Measured: 0-12 months
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
Measured: 0-12 months
Change in VagusTM Test
A measurement for autonomic neuropathy by evaluation of heart rate in different positions
Measured: 0-12 months
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
Measured: 0-12 months
Change in vitamin B12-level in blood test
Measurement of deficiency/functional deficiency
Measured: 0-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start14 Aug 2020
- Primary completion30 Aug 2023
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy-induced Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University
- Responsible party
- Principal investigator, Marianne Tang Severinsen, Aalborg University Hospital
- Investigators
- Marianne T Severinsen, MD, PhD, Principal investigator, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04393363
- Sponsor's protocol ID
- N-20190068
- Acronym
- NOVIT1
- Status last verified
- Jan 2024
- First submitted
- 14 May 2020
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40011273
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection and Prevention of Neuropathy and Cognitive Impairment Following Treatment for Haematological Malignancies (the NOVIT Study)
- ClinicalTrials.gov ID
- NCT04393363
- Acronym / sponsor ID
- NOVIT1 / N-20190068
- Keywords
- vincristine, bortezomib, lenalidomide, Assessment of nerve fiber excitability
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Collaborators
- Aalborg University
- Study start
- 14 Aug 2020 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Haematological patients scheduled for (but not started) treatment with vincristine, bortezomib or lenalidomid regardless of type of haematological malignancy.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in neuropathy assessed by change in the neurotoxicity (ntx)-subscale of the FACT/GOG-Ntx-13-Score
Time frame: 0-12 months
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
9 secondary outcomes
Change in nerve excitability assessed by Perception Threshold Tracking
Time frame: 0-12 months
Change in The National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Time frame: 0-12 months
Change in the Total Neuropathy Score-Clinical
Time frame: 0-12 months
Change in Quality of Life (The total FACT/GOG-Ntx-score)
Time frame: 0-12 months
Change in Montreal Cognitive Assessment (MoCA)
Time frame: 0-12 months
Change in the score for FACT/GOG-cog
Time frame: 0-12 months
Change in VagusTM Test
Time frame: 0-12 months
Change in Bioimpendance
Time frame: 0-12 months
Change in vitamin B12-level in blood test
Time frame: 0-12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Derived from this study: PubMed 40011273Maksten 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.
- Individual participant dataSharing planned: Undecided
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Continuous Controlled Cooling for Prevention of Chemotherapy-Induced Peripheral Neuropathy
Chemotherapy Induced Peripheral Neuropathy (CIPN)
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Relationship Between Great Toe Strength And Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
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Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marianne T Severinsen, MD, PhD principal investigator
Aalborg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chemotherapy-induced Peripheral Neuropathy, run by Aalborg University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in neuropathy assessed by change in the neurotoxicity (ntx)-subscale of the FACT/GOG-Ntx-13-Score (time frame: 0-12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04393363, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.