Wearable Focal Vibration for Chemotherapy-Induced Peripheral Neuropathy
NCT04959929
Chemotherapy-induced Peripheral Neuropathy
Oklahoma City, Oklahoma, United States
View Trial DetailsNCT Number: NCT05781425
Investigation of which patients treated with bortezomib that have increased risk of developing peripheral neuropathy.
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Notify Me18 year and older
All sexes
Observational
Blood Diseases - Aarhus University Hospital, Aarhus, Denmark
The study aims to include 20 patients with multiple myeloma that are initiating bortezomib treatment. The patients must follow their normal treatment cycles while getting blood drawn during their treatment period however maximal 9 cycles.
Blood is dawn before treatment initiation and approximately once per cycle in order to measure neurofilament light chain (NFL) before and during treatment. The primary outcome is to relate the level of NFL during treatment with the level at baseline and as a secondary outcome to relate the level of NFL to the cumulative dose of bortezomib.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline (before treatment initiation)
Plasma neurofilament light chain before treatment with bortezomib. (Cycle length can vary).
Time frame: Between day 8 and 15 in cycle 1 (each cycle is often between 3-6 weeks)
Plasma neurofilament light chain during treatment with bortezomib.
Time frame: Day 1 in cycle 2 (each cycle is often between 3-6 weeks)
Plasma neurofilament light chain during treatment with bortezomib. (Cycle length can vary).
Time frame: Day 1 in cycle 3 (each cycle is often between 3-6 weeks)
Plasma neurofilament light chain during treatment with bortezomib. (Cycle length can vary).
Time frame: Day 1 in cycle 4 (each cycle is often between 3-6 weeks)
Plasma neurofilament light chain during treatment with bortezomib. (Cycle length can vary).
Time frame: Day 1 in cycle 5 (each cycle is often between 3-6 weeks)
Plasma neurofilament light chain during treatment with bortezomib. (Cycle length can vary).
Time frame: Day 1 in cycle 6 (each cycle is often between 3-6 weeks)
Plasma neurofilament light chain during treatment with bortezomib. (Cycle length can vary).
Time frame: Day 1 in cycle 7 (each cycle is often between 3-6 weeks)
Plasma neurofilament light chain during treatment with bortezomib. (Cycle length can vary).
Time frame: Day 1 in cycle 8 (each cycle is often between 3-6 weeks)
Plasma neurofilament light chain during treatment with bortezomib. (Cycle length can vary).
Time frame: Day 1 in cycle 9 (each cycle is often between 3-6 weeks)
Plasma neurofilament light chain during treatment with bortezomib. (Cycle length can vary).
Time frame: From cycle 1 (each cycle is often between 3-6 weeks) and forward, maximum 9 cycles in total. An average of 1 year.
Plasma neurofilament light chain relative to the cumulative dose of bortezomib in patients.
Time frame: From cycle 1 (each cycle is often between 3-6 weeks) and forward, maximum 9 cycles in total. An average of 1 year.
Using questionnaire Chemotherapy-induced peripheral neuropathy 20 (CIPN20), grading
Time frame: From cycle 1 (each cycle is often between 3-6 weeks) and forward, maximum 9 cycles in total. An average of 1 year.
Using Common Terminology Criteria for Adverse Events (CTCAE) version 5, grading 1-5 with 1 being the mildest case and 5 being the worst.
Odense University Hospital
Other
Neurofilament Light Chain as Biomarker for Bortezomib-induced Peripheral Neuropathy
Acronym: NFL-BIOPAIN
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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