Clinical trial · Interventional
Cryocompression Therapy for Peripheral Neuropathy in Patients With Multiple Myeloma
Cryocompression for Bortezomib-Induced Peripheral Neuropathy Among Multiple Myeloma Patients
NCT03870451CI-TRIAL-00081959terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low accruals
Summary
Brief summary (as posted)
This trial studies how well cryocompression therapy works in reducing bortezomib-induced peripheral neuropathy in patients with multiple myeloma. Peripheral neuropathy (nerve pain or tingling in hands or feet) is a common side effect of chemotherapy such as bortezomib that affects the quality of life and amount of chemotherapy that can be given to many cancer patients. Cryocompression is a treatment where a glove and a boot are worn to cool down the skin. This cooling treatment is safe and does not interfere with chemotherapy treatment. Daily cryocompression therapy may reduce neuropathy caused by bortezomib chemotherapy.
Conditions
Conditions (2)
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 | — |
| Plasma Cell Myeloma | Multiple Myeloma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| VascuTherm5 vascular compression device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort 1 VascuTherm5 vascular compression device
- description
- VascuTherm5 vascular compression device Cohort 1 - Grade 2-3 neuropathy - Patients with established neuropathy (e.g. previously received bortezomib-based chemotherapy and have clinically documented CTCAE grade 2 or 3 neuropathies. Patients undergo home cryocompression therapy treatments using VascuTherm device on their non-dominant hand and foot over 30 minutes daily for 8 weeks.
- interventionNames
- Device: VascuTherm5 vascular compression device
- type
- EXPERIMENTAL
- label
- Cohort 2 VascuTherm5 vascular compression device
- description
- VascuTherm5 vascular compression device Cohort 2 Grade 1-2 Neuropathy - Patients with new-onset neuropathy (e.g. currently receiving bortezomib-based chemotherapy have clinically documented CTCAE grade 1 or grade 2 neuropathy to explore its role in preventing worsening of CIPN in patients receiving neurotoxic chemotherapy. Patients undergo home cryocompression therapy treatments using VascuTherm device on their non-dominant hand and foot over 30 minutes daily for 8 weeks.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have histologically or cytologically confirmed multiple myeloma (any International Staging System \[ISS\] stage). * Clinical symptoms of bortezomib-induced peripheral neuropathy as measured by the NCI-CTCAE. Cohort 1: Patients with clinically documented CTCAE grade greater than or equal 2 neuropathy. Cohort 2: Patients with clinically documented CTCAE grade 1-2 neuropathy. • Currently or previously received bortezomib-containing regimen Cohort 1: Patients who have previously received a bortezomib-containing regimen and have clinically documented neuropathy that is attributed to the bortezomib containing regimen. Cohort 2: Patients who are currently receiving a bortezomib-containing regimen and have clinically documented neuropathy that is attributed to the bortezomib containing regimen. * Age must be greater than or equal to 18 years. * Eastern Cooperative Oncology Group (ECOG) =\< 4. * Life expectancy \>= 6 months. * Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document. Exclusion Criteria: * Self-reported or documented history of pre-existing peripheral neuropathy prior to initiation of bortezomib therapy. * Other explanatory etiology for neuropathy. * Presumptive evidence of congestive heart failure. * Current deep vein thrombosis or pulmonary embolism (diagnosed within the past 6 months). * Current pulmonary edema. * Unable to provide accurate medical history. * Pregnant women are excluded from this study because they will not be receiving myeloma standard of care (SOC) therapy or bortezomib-based therapy per inclusion criteria. * Current or previously documented inflammatory phlebitis; thrombophlebitis; decompensated cardiac insufficiency; arterial dysregulation; erysipelas; carcinoma or carcinoma metastasis in the affected extremity; decompensated hypotonia; venous or arterial occlusive disease; or Raynaud's disease; * Current monoclonal gammopathy of undetermined significance (MGUS), Waldenstroms macroglobulinemia, or Castleman disease.
References
Publications (0)
Data not yet available
No reference posted for this study.