TriangleNCT04505553 · OUTCOME
Change in Severity of Chemotherapy-induced Peripheral Neuropathy (CIPN) From Baseline to 3 Months
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
- Full Range
- Time frame
- At 3 months
What was measured
Measured by the European Organization for Research and Treatment of Cancer (EORTC)-CIPN 20. Severity of CIPN will be summarized for each treatment arm, and treatment comparisons made via linear regression model with adjustment for baseline severity level. The EORTC QLQ-CIPN20 is a 20-item questionnaire that evaluates CIPN using 3 subscales that assess sensory (9 items), motor (8 items), and autonomic (3 items) symptoms and functioning. The CIPN-20 subscale raw scores are linearly converted to a 0-100 scale such that a high score corresponds to a worse condition or more symptoms. Change in severity was measured by the difference in the converted scores from baseline to three months and the range is -100 to 100.
Analysis population: Due to missing patient reported outcomes the overall number of participants analyzed differs from patients that completed the study.
Groups in this outcome
Arm I (Acupuncture, Acupressure, Cryotherapy)
Patients undergo acupuncture during chemotherapy infusion on day 1 and fluorouracil pump disconnect on day 3 of each biweekly chemotherapy infusion over 12 weeks. Patients also undergo self-administered acupressure over 11 minutes daily for 12 weeks and undergo standard of care oral cryotherapy. Acupuncture Therapy: Undergo acupuncture Acupressure Therapy: Undergo acupressure Oral Cryotherapy: Undergo oral cryotherapy Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies
Arm II (Cryotherapy)
Patients undergo standard of care oral cryotherapy. Oral Cryotherapy: Undergo oral cryotherapy Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies
| Group | Source count |
|---|---|
| Arm I (Acupuncture, Acupressure, Cryotherapy) | 20 |
| Arm II (Cryotherapy) | 27 |
Reported measurements
Sensory Subscale
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Acupuncture, Acupressure, Cryotherapy) | 5.9 | Not reported | -7.4 | 37.0 | Not reported |
| Arm II (Cryotherapy) | 9.1 | Not reported | -11.1 | 25.9 | Not reported |
Motor Subscale
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Acupuncture, Acupressure, Cryotherapy) | 1.9 | Not reported | -16.7 | 12.5 | Not reported |
| Arm II (Cryotherapy) | 5.7 | Not reported | -4.2 | 25.0 | Not reported |
Autonomic Subscale
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Acupuncture, Acupressure, Cryotherapy) | 0.6 | Not reported | -33.3 | 22.2 | Not reported |
| Arm II (Cryotherapy) | 0.8 | Not reported | -50.0 | 44.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -7.4
- upper Limit
- 37.0
- value
- 5.9
- group Id
- OG001
- lower Limit
- -11.1
- upper Limit
- 25.9
- value
- 9.1
- title
- Sensory Subscale
- categories
- measurements
- group Id
- OG000
- lower Limit
- -16.7
- upper Limit
- 12.5
- value
- 1.9
- group Id
- OG001
- lower Limit
- -4.2
- upper Limit
- 25.0
- value
- 5.7
- title
- Motor Subscale
- categories
- measurements
- group Id
- OG000
- lower Limit
- -33.3
- upper Limit
- 22.2
- value
- 0.6
- group Id
- OG001
- lower Limit
- -50.0
- upper Limit
- 44.4
- value
- 0.8
- title
- Autonomic Subscale
- denoms
- counts
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 27
- units
- Participants
- description
- Measured by the European Organization for Research and Treatment of Cancer (EORTC)-CIPN 20. Severity of CIPN will be summarized for each treatment arm, and treatment comparisons made via linear regression model with adjustment for baseline severity level. The EORTC QLQ-CIPN20 is a 20-item questionnaire that evaluates CIPN using 3 subscales that assess sensory (9 items), motor (8 items), and autonomic (3 items) symptoms and functioning. The CIPN-20 subscale raw scores are linearly converted to a 0-100 scale such that a high score corresponds to a worse condition or more symptoms. Change in severity was measured by the difference in the converted scores from baseline to three months and the range is -100 to 100.
- dispersion Type
- Full Range
- groups
- description
- Patients undergo acupuncture during chemotherapy infusion on day 1 and fluorouracil pump disconnect on day 3 of each biweekly chemotherapy infusion over 12 weeks. Patients also undergo self-administered acupressure over 11 minutes daily for 12 weeks and undergo standard of care oral cryotherapy. Acupuncture Therapy: Undergo acupuncture Acupressure Therapy: Undergo acupressure Oral Cryotherapy: Undergo oral cryotherapy Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies
- id
- OG000
- title
- Arm I (Acupuncture, Acupressure, Cryotherapy)
- description
- Patients undergo standard of care oral cryotherapy. Oral Cryotherapy: Undergo oral cryotherapy Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies
- id
- OG001
- title
- Arm II (Cryotherapy)
- param Type
- MEAN
- population Description
- Due to missing patient reported outcomes the overall number of participants analyzed differs from patients that completed the study.
- reporting Status
- POSTED
- time Frame
- At 3 months
- title
- Change in Severity of Chemotherapy-induced Peripheral Neuropathy (CIPN) From Baseline to 3 Months
- type
- PRIMARY
- unit Of Measure
- units on a scale
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Preserved source evidence · Not medical advice