TriangleNCT03870451 · OUTCOME
EORTC QLQ-CIPN20 Questionnaire
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- score on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline, 4 weeks, 8 weeks
What was measured
Chemotherapy-induced peripheral neuropathy (CIPN) is characterized by numbness, tingling, and shooting/burning pain. Patient-reported assessment of neuropathy based on 19 questions from components of sensory, motor, and autonomic neuropathic. Question responses are (scale of 1 to 4) 1 being "not at all" and 4 being "very much." The total EORTC score (calculated as the average of the component responses) (range 1-4) and then converted to a 100 point scale (range 0-100) with higher scores having more severe symptoms or greater functional limitation. EORTC QLQ-CIPN20 (PRO) will be done at baseline, and at 4 and 8 weeks of cryocompression therapy.
Analysis population: 18 completed baseline, 14 completed 4 week assessment, 16 completed 8 week assessment. Decreased sample sizes at 4 and 8 weeks is due to patient withdrawal and patient refusals.
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 | 12 |
| Grade 1-2 New-onset Neuropathy | 6 |
Reported measurements
Baseline
| Group | Source count |
|---|---|
| Grade 2-3 Established Neuropathy | 12 |
| Grade 1-2 New-onset Neuropathy | 6 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Grade 2-3 Established Neuropathy | 39 | 17 | Not reported | Not reported | Not reported |
| Grade 1-2 New-onset Neuropathy | 30 | 8 | Not reported | Not reported | Not reported |
4 weeks
| Group | Source count |
|---|---|
| Grade 2-3 Established Neuropathy | 9 |
| Grade 1-2 New-onset Neuropathy | 5 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Grade 2-3 Established Neuropathy | 27 | 11 | Not reported | Not reported | Not reported |
| Grade 1-2 New-onset Neuropathy | 25 | 12 | Not reported | Not reported | Not reported |
8 weeks
| Group | Source count |
|---|---|
| Grade 2-3 Established Neuropathy | 10 |
| Grade 1-2 New-onset Neuropathy | 6 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Grade 2-3 Established Neuropathy | 28 | 15 | Not reported | Not reported | Not reported |
| Grade 1-2 New-onset Neuropathy | 22 | 7 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 17
- value
- 39
- group Id
- OG001
- spread
- 8
- value
- 30
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 6
- units
- Participants
- title
- Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 11
- value
- 27
- group Id
- OG001
- spread
- 12
- value
- 25
- denoms
- counts
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 5
- units
- Participants
- title
- 4 weeks
- categories
- measurements
- group Id
- OG000
- spread
- 15
- value
- 28
- group Id
- OG001
- spread
- 7
- value
- 22
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 6
- units
- Participants
- title
- 8 weeks
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 6
- units
- Participants
- description
- Chemotherapy-induced peripheral neuropathy (CIPN) is characterized by numbness, tingling, and shooting/burning pain. Patient-reported assessment of neuropathy based on 19 questions from components of sensory, motor, and autonomic neuropathic. Question responses are (scale of 1 to 4) 1 being "not at all" and 4 being "very much." The total EORTC score (calculated as the average of the component responses) (range 1-4) and then converted to a 100 point scale (range 0-100) with higher scores having more severe symptoms or greater functional limitation. EORTC QLQ-CIPN20 (PRO) will be done at baseline, and at 4 and 8 weeks of cryocompression therapy.
- 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
- 18 completed baseline, 14 completed 4 week assessment, 16 completed 8 week assessment. Decreased sample sizes at 4 and 8 weeks is due to patient withdrawal and patient refusals.
- reporting Status
- POSTED
- time Frame
- Baseline, 4 weeks, 8 weeks
- title
- EORTC QLQ-CIPN20 Questionnaire
- type
- SECONDARY
- unit Of Measure
- score on a scale
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Preserved source evidence · Not medical advice