NCT03870451 · OUTCOME
Sensory Response Evaluability at Baseline and 8 Weeks
Cryocompression Therapy for Peripheral Neuropathy in Patients With Multiple Myeloma · Source last updated 2026-10-13
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- number patients
- Interval / dispersion
- Not reported
- Time frame
- Baseline, 8 weeks
What was measured
Sural sensory response (collected as yes/no) measured on both the left and right ankles at baseline and 8 weeks for amplitude, onset latency, and peak latency. Reported are the number with sural sensory response measured (yes).
Analysis population: The number at each timepoint/side is different due to loss in follow-up, patient refusal, and measurement difficulties leading to missing data.
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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Grade 2-3 Established Neuropathy | 11 |
|---|
| Grade 1-2 New-onset Neuropathy | 6 |
|---|
Reported measurements
Baseline - Amplitude response - Right Sural ANKLE (Calf)
Analysis denominator · Participants
| Group | Source count |
|---|
| Grade 2-3 Established Neuropathy | 9 |
|---|
| Grade 1-2 New-onset Neuropathy | 5 |
|---|
Values in number patients · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Grade 2-3 Established Neuropathy | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 1-2 New-onset Neuropathy | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Baseline - Amplitude response - Left Sural ANKLE (Calf)
Analysis denominator · Participants
| Group | Source count |
|---|
| Grade 2-3 Established Neuropathy | 10 |
|---|
| Grade 1-2 New-onset Neuropathy | 5 |
|---|
Values in number patients · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Grade 2-3 Established Neuropathy | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 1-2 New-onset Neuropathy | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
8 weeks - Amplitude response - Right Sural ANKLE (Calf)
Analysis denominator · Participants
| Group | Source count |
|---|
| Grade 2-3 Established Neuropathy | 10 |
|---|
| Grade 1-2 New-onset Neuropathy | 6 |
|---|
Values in number patients · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Grade 2-3 Established Neuropathy | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 1-2 New-onset Neuropathy | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
8 Weeks - Amplitude response - Left Sural ANKLE (Calf)
Analysis denominator · Participants
| Group | Source count |
|---|
| Grade 2-3 Established Neuropathy | 10 |
|---|
| Grade 1-2 New-onset Neuropathy | 6 |
|---|
Values in number patients · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Grade 2-3 Established Neuropathy | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 1-2 New-onset Neuropathy | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Baseline - Onset Latency response - Right Sural ANKLE (Calf)
Analysis denominator · Participants
| Group | Source count |
|---|
| Grade 2-3 Established Neuropathy | 10 |
|---|
| Grade 1-2 New-onset Neuropathy | 5 |
|---|
Values in number patients · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Grade 2-3 Established Neuropathy | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 1-2 New-onset Neuropathy | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Baseline - Onset Latency response - Left Sural ANKLE (Calf)
Analysis denominator · Participants
| Group | Source count |
|---|
| Grade 2-3 Established Neuropathy | 11 |
|---|
| Grade 1-2 New-onset Neuropathy | 5 |
|---|
Values in number patients · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Grade 2-3 Established Neuropathy | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 1-2 New-onset Neuropathy | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
8 weeks - Onset Latency response - Right Sural ANKLE (Calf)
Analysis denominator · Participants
| Group | Source count |
|---|
| Grade 2-3 Established Neuropathy | 10 |
|---|
| Grade 1-2 New-onset Neuropathy | 6 |
|---|
Values in number patients · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Grade 2-3 Established Neuropathy | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 1-2 New-onset Neuropathy | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
8 weeks - Onset Latency response - Left Sural ANKLE (Calf)
Analysis denominator · Participants
| Group | Source count |
|---|
| Grade 2-3 Established Neuropathy | 10 |
|---|
| Grade 1-2 New-onset Neuropathy | 6 |
|---|
Values in number patients · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Grade 2-3 Established Neuropathy | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 1-2 New-onset Neuropathy | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Baseline - Peak Latency response - Right Sural ANKLE (Calf)
Analysis denominator · Participants
| Group | Source count |
|---|
| Grade 2-3 Established Neuropathy | 10 |
|---|
| Grade 1-2 New-onset Neuropathy | 5 |
|---|
Values in number patients · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Grade 2-3 Established Neuropathy | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 1-2 New-onset Neuropathy | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Baseline - Peak Latency response - Left Sural ANKLE (Calf)
Analysis denominator · Participants
| Group | Source count |
|---|
| Grade 2-3 Established Neuropathy | 11 |
|---|
| Grade 1-2 New-onset Neuropathy | 5 |
|---|
Values in number patients · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Grade 2-3 Established Neuropathy | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 1-2 New-onset Neuropathy | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
8 weeks - Peak Latency response - Right Sural ANKLE (Calf)
Analysis denominator · Participants
| Group | Source count |
|---|
| Grade 2-3 Established Neuropathy | 10 |
|---|
| Grade 1-2 New-onset Neuropathy | 6 |
|---|
Values in number patients · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Grade 2-3 Established Neuropathy | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 1-2 New-onset Neuropathy | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
8 weeks - Peak Latency response - Left Sural ANKLE (Calf)
Analysis denominator · Participants
| Group | Source count |
|---|
| Grade 2-3 Established Neuropathy | 10 |
|---|
| Grade 1-2 New-onset Neuropathy | 6 |
|---|
Values in number patients · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Grade 2-3 Established Neuropathy | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 1-2 New-onset Neuropathy | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 5
- units
- Participants
- title
- Baseline - Amplitude response - Right Sural ANKLE (Calf)
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 5
- units
- Participants
- title
- Baseline - Amplitude response - Left Sural ANKLE (Calf)
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 6
- units
- Participants
- title
- 8 weeks - Amplitude response - Right Sural ANKLE (Calf)
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 3
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 6
- units
- Participants
- title
- 8 Weeks - Amplitude response - Left Sural ANKLE (Calf)
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 5
- units
- Participants
- title
- Baseline - Onset Latency response - Right Sural ANKLE (Calf)
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 5
- units
- Participants
- title
- Baseline - Onset Latency response - Left Sural ANKLE (Calf)
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 6
- units
- Participants
- title
- 8 weeks - Onset Latency response - Right Sural ANKLE (Calf)
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 3
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 6
- units
- Participants
- title
- 8 weeks - Onset Latency response - Left Sural ANKLE (Calf)
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 5
- units
- Participants
- title
- Baseline - Peak Latency response - Right Sural ANKLE (Calf)
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 5
- units
- Participants
- title
- Baseline - Peak Latency response - Left Sural ANKLE (Calf)
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 6
- units
- Participants
- title
- 8 weeks - Peak Latency response - Right Sural ANKLE (Calf)
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 3
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 6
- units
- Participants
- title
- 8 weeks - Peak Latency response - Left Sural ANKLE (Calf)
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 6
- units
- Participants
- description
- Sural sensory response (collected as yes/no) measured on both the left and right ankles at baseline and 8 weeks for amplitude, onset latency, and peak latency. Reported are the number with sural sensory response measured (yes).
- 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
- NUMBER
- population Description
- The number at each timepoint/side is different due to loss in follow-up, patient refusal, and measurement difficulties leading to missing data.
- reporting Status
- POSTED
- time Frame
- Baseline, 8 weeks
- title
- Sensory Response Evaluability at Baseline and 8 Weeks
- type
- SECONDARY
- unit Of Measure
- number patients
Download exact source JSON → · Snapshot ctgov-results-d643ffaf417bcef6d45eb5e0
Preserved source evidence · Not medical advice
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