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Vitamin D and neuralgia in multiple myeloma


- candidate number24704
- NTR NumberNTR5990
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-jul-2016
- Secondary IDsRTPO 985 
- Public TitleVitamin D and neuralgia in multiple myeloma
- Scientific TitleVitamin D status and peripheral neuropathy in multiple myeloma patients.
- ACRONYM
- hypothesisDecreased levels of vitamin D is associated with the occurence of peripheral neuropathy in multiple myeloma patients.
- Healt Condition(s) or Problem(s) studiedNeuropathy , Multiple myeloma, Vitamin D
- Inclusion criteriaPatients with smoldering or symptomatic multiple myeloma
Patients 18 years or older
Able to give informed consent
- Exclusion criteriaNone
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 26-sep-2016
- planned closingdate27-jan-2017
- Target number of participants120
- Interventions- Blood samples will be drawn to determine 25-hydroxyvitamin D levels.
- All patients will complete the self-assessment survey ICPNQ and when necessary the VAS score, to distinguish different PN grades in MM patients.
- Primary outcomeThe correlation between PN and the vitamin D status in MM patients.
- Secondary outcome- to evaluate the influence of vitamin D on the severity of PN
- to determine the correspondence of the ICPNQ results and patientsí records.
- the number of patients with low 25-hydroxyvitamin D serum levels
- to search for differences in incidence of PN for each drug
- TimepointsVitamin D levels and neuropathy grading will be determined at one timepoint.
- Trial web site
- status[default]
- CONTACT FOR PUBLIC QUERIES Berdien Oortgiesen
- CONTACT for SCIENTIFIC QUERIES Berdien Oortgiesen
- Sponsor/Initiator Medical Center Leeuwarden
- Funding
(Source(s) of Monetary or Material Support)
Wetenschapsfonds MCL, Leeuwarden, The Netherlands
- Publications
- Brief summaryVitamin D status and peripheral neuropathy in multiple myeloma patients

Background: Randomized controlled trials have shown that the introduction of the novel agents bortezomib, thalidomide and lenalidomide have improved response rates, progression-free survival and overall survival. However, chemotherapy-induced peripheral neuropathy (CIPN), especially when using bortezomib, is a common adverse event. In addition, several studies have found that up to 54% of MM patients have peripheral neuropathy (PN) at diagnosis, indicating that the disease itself can also induce PN. PN decreases quality of life and requires dose adjustment, delay or premature termination of the treatment, resulting in a negative influence on time to progression and survival. Vitamin D was found to reduce polyneuropathy in diabetes mellitus type 2 patients and a possible mechanism was found in animal trials, where the investigators found an increase of nerve growth factor in diabetic rats after supplementation of vitamin D. Recently, it was found that vitamin D deficient MM patients were more likely to have severe CIPN (>grade 2) of both motor and sensory PN. In this study we want to confirm the relationship of vitamin D status and the occurrence and severity of PN in MM patients.

Objectives: The primary objective of this study is to determine the correlation between the 25- hydroxyvitamin D serum levels and PN in patients with multiple myeloma. Secondary objectives are to evaluate the influence of different vitamin D levels on the severity of PN; to search for differences in prevalence of PN for each drug; to determine the correspondence of the ICPNQ results and patients' records and to gain insight in the number of patients with inadequate 25-hydroxyvitamin D serum levels (< 75 nmol/l).

Study design: This is an observational study. Blood samples will be drawn to determine vitamin D levels and the ICPNQ Questionnaire, a validated questionnaire to distinguish different PN grades in MM patients, will be completed. VAS scores will be used to grade the intensity of PN.

Study population: Patients with smoldering or symptomatic multiple myeloma in the Medical Centre Leeuwarden are included in the study. Patients must be over 18 years of age and must be able to give informed consent.

Burden and risks: Preventing CIPN is of great importance for the continuation of chemotherapy and a prolonged exposure will presumably result in a higher survival rate and an improved quality of life. When this study confirms the relationship between vitamin D and neuropathy, new opportunities for the prevention of PN may arise. As blood sampling is performed frequently in myeloma patients and the questionnaire can be filled in within minutes, the burden for the patients is minimal.
- Main changes (audit trail)
- RECORD28-jul-2016 - 29-sep-2016


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