TriangleNCT01783522 · OUTCOME
Degree of Peripheral Neuropathy (PNP)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- units on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- up to 4 months from start of study
What was measured
The Neuropathy Impairment Score -Lower Limbs (NIS-LL) is the objective measurement of PNP symptoms. The degree of PNP will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03. The CTCAE is a 0-5 scale that assesses severity of neuropathy related to cancer therapy with higher scores meaning more symptoms A difference of 2 points between groups is considered significant. This measure will be performed at baseline and at 4 months.
Analysis population: All participants enrolled in study and given treatment.
Groups in this outcome
Arm I (Preventative Nutritional Supplementation)
Patients receive glutamine PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity. glutamine: Dose of 15 grams twice times daily (to equal 30 grams a day) for a period of 4 months. quality-of-life assessment: Ancillary studies
Arm II (Placebo)
Patients receive placebo PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity. quality-of-life assessment: Ancillary studies placebo: Given PO
| Group | Source count |
|---|---|
| Arm I (Preventative Nutritional Supplementation) | 4 |
| Arm II (Placebo) | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Preventative Nutritional Supplementation) | 3.40 | 7.83 | Not reported | Not reported | Not reported |
| Arm II (Placebo) | 3.40 | 7.83 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 7.83
- value
- 3.40
- group Id
- OG001
- spread
- 7.83
- value
- 3.40
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 5
- units
- Participants
- description
- The Neuropathy Impairment Score -Lower Limbs (NIS-LL) is the objective measurement of PNP symptoms. The degree of PNP will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03. The CTCAE is a 0-5 scale that assesses severity of neuropathy related to cancer therapy with higher scores meaning more symptoms A difference of 2 points between groups is considered significant. This measure will be performed at baseline and at 4 months.
- dispersion Type
- Standard Deviation
- groups
- description
- Patients receive glutamine PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity. glutamine: Dose of 15 grams twice times daily (to equal 30 grams a day) for a period of 4 months. quality-of-life assessment: Ancillary studies
- id
- OG000
- title
- Arm I (Preventative Nutritional Supplementation)
- description
- Patients receive placebo PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity. quality-of-life assessment: Ancillary studies placebo: Given PO
- id
- OG001
- title
- Arm II (Placebo)
- param Type
- MEAN
- population Description
- All participants enrolled in study and given treatment.
- reporting Status
- POSTED
- time Frame
- up to 4 months from start of study
- title
- Degree of Peripheral Neuropathy (PNP)
- type
- PRIMARY
- unit Of Measure
- units on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice