TriangleNCT03870451 · OUTCOME
Change in Motor Nerve Function (Conduction Velocity) From Baseline to 8 Weeks
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- m/s
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline, 8 weeks
What was measured
Change in tibial motor response from baseline to 8 weeks will include conduction velocity (m/sec).
Analysis population: The number in this outcome was determined by the number of participants completing both baseline and 8 week evaluations.
Groups in this outcome
Grade 2-3 Established Neuropathy
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. VascuTherm5 vascular compression device: VascuTherm5 vascular compression unit to function as an intermittent external pneumatic compression device
Grade 1-2 New-onset Neuropathy
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. VascuTherm5 vascular compression device: VascuTherm5 vascular compression unit to function as an intermittent external pneumatic compression device
| Group | Source count |
|---|---|
| Grade 2-3 Established Neuropathy | 10 |
| Grade 1-2 New-onset Neuropathy | 6 |
Reported measurements
Right Median Elbow
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Grade 2-3 Established Neuropathy | 0.2 | 2.8 | Not reported | Not reported | Not reported |
| Grade 1-2 New-onset Neuropathy | -1.0 | 1.3 | Not reported | Not reported | Not reported |
Left Median Elbow
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Grade 2-3 Established Neuropathy | 0.2 | 4.0 | Not reported | Not reported | Not reported |
| Grade 1-2 New-onset Neuropathy | -0.3 | 3.0 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 2.8
- value
- 0.2
- group Id
- OG001
- spread
- 1.3
- value
- -1.0
- title
- Right Median Elbow
- categories
- measurements
- group Id
- OG000
- spread
- 4.0
- value
- 0.2
- group Id
- OG001
- spread
- 3.0
- value
- -0.3
- title
- Left Median Elbow
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 6
- units
- Participants
- description
- Change in tibial motor response from baseline to 8 weeks will include conduction velocity (m/sec).
- dispersion Type
- Standard Deviation
- groups
- 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. VascuTherm5 vascular compression device: VascuTherm5 vascular compression unit to function as an intermittent external pneumatic compression device
- id
- OG000
- title
- Grade 2-3 Established Neuropathy
- 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. VascuTherm5 vascular compression device: VascuTherm5 vascular compression unit to function as an intermittent external pneumatic compression device
- id
- OG001
- title
- Grade 1-2 New-onset Neuropathy
- param Type
- MEAN
- population Description
- The number in this outcome was determined by the number of participants completing both baseline and 8 week evaluations.
- reporting Status
- POSTED
- time Frame
- Baseline, 8 weeks
- title
- Change in Motor Nerve Function (Conduction Velocity) From Baseline to 8 Weeks
- type
- SECONDARY
- unit Of Measure
- m/s
Download exact source JSON → · Snapshot ctgov-results-d643ffaf417bcef6d45eb5e0
Preserved source evidence · Not medical advice