NCT01346267 · OUTCOME
Efficacy of Treatment on CIN During Delayed Phase of Chemotherapy
Acupressure in Controlling Nausea in Young Patients Receiving Highly Emetogenic Chemotherapy · Source last updated 2021-08-18
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Maximum of 7 days after Acute Phase
What was measured
CIN = Chemotherapy-Induced Nausea. The delayed phase began at the end of the acute phase and continued until the first chemotherapy dose of the next chemotherapy block. Delayed Phase - Bands will continue to be worn for a maximum of 7 days or until the next chemotherapy cycle starts, whichever comes first. Nausea severity is defined as the maximum PeNAT (Pediatric Nausea Assessment Tool) score observed during each 24 hour period. The possible scores for the pediatric nausea assessment tool are no nausea, mild nausea, moderate nausea, severe nausea. Only patients who contributed at least 1 PeNAT score during the delayed phase were included.
Analysis population: The overall number of patients analyzed is 83 for Arm I and 82 for Arm II. Patients analyzed include the total number of patients that reported at least 1 PeNAT (Pediatric Nausea Assessment Tool) score on that day. The duration of the acute phase varied with chemotherapy regimen, according to study design. The number of patients receiving chemotherapy for longer than 3 days diminished each day, so days 4-7 were collapsed and considered a single day.
Groups in this outcome
Arm I- Real Acupressure Bands
Patients wear Sea-Band acupressure wristbands on each wrist beginning approximately 30 minutes prior to the first cisplatin-containing chemotherapy course and continually for 24 hours after the last chemotherapy dose (acute phase), and for a maximum of 7 days or until the next chemotherapy course starts (delayed phase). Patients are allowed to take bands off intermittently (up to 4 times a day, for no more than 15 minutes each time) to relieve pressure or to bathe. Patients also receive standard of care anti-emetic prophylaxis comprising granisetron, ondansetron, or dexamethasone during chemotherapy according to institutional or physician preference.
Real Acupressure Band: Acupressure wristband
Arm II- Placebo Acupressure Bands
Patients wear placebo wristbands on each wrist and receive standard of care anti-emetic prophylaxis during chemotherapy as patients in arm I.
Placebo Acupressure Band: Sham wristband
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 |
|---|
| Arm I- Real Acupressure Bands | 83 |
|---|
| Arm II- Placebo Acupressure Bands | 82 |
|---|
Reported measurements
Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm I- Real Acupressure Bands | 75 |
|---|
| Arm II- Placebo Acupressure Bands | 68 |
|---|
No Nausea
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm I- Real Acupressure Bands | 27 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm II- Placebo Acupressure Bands | 27 | Not reported | Not reported | Not reported | Not reported |
|---|
Mild Nausea
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm I- Real Acupressure Bands | 19 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm II- Placebo Acupressure Bands | 15 | Not reported | Not reported | Not reported | Not reported |
|---|
Moderate Nausea
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm I- Real Acupressure Bands | 19 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm II- Placebo Acupressure Bands | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
Severe Nausea
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm I- Real Acupressure Bands | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm II- Placebo Acupressure Bands | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
Day 2
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm I- Real Acupressure Bands | 67 |
|---|
| Arm II- Placebo Acupressure Bands | 62 |
|---|
No Nausea
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm I- Real Acupressure Bands | 28 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm II- Placebo Acupressure Bands | 25 | Not reported | Not reported | Not reported | Not reported |
|---|
Mild Nausea
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm I- Real Acupressure Bands | 15 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm II- Placebo Acupressure Bands | 20 | Not reported | Not reported | Not reported | Not reported |
|---|
Moderate Nausea
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm I- Real Acupressure Bands | 15 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm II- Placebo Acupressure Bands | 12 | Not reported | Not reported | Not reported | Not reported |
|---|
Severe Nausea
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm I- Real Acupressure Bands | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm II- Placebo Acupressure Bands | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
Day 3
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm I- Real Acupressure Bands | 65 |
|---|
| Arm II- Placebo Acupressure Bands | 61 |
|---|
No Nausea
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm I- Real Acupressure Bands | 28 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm II- Placebo Acupressure Bands | 33 | Not reported | Not reported | Not reported | Not reported |
|---|
Mild Nausea
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm I- Real Acupressure Bands | 21 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm II- Placebo Acupressure Bands | 14 | Not reported | Not reported | Not reported | Not reported |
|---|
Moderate Nausea
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm I- Real Acupressure Bands | 12 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm II- Placebo Acupressure Bands | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
Severe Nausea
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm I- Real Acupressure Bands | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm II- Placebo Acupressure Bands | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
Days 4-7
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm I- Real Acupressure Bands | 56 |
|---|
| Arm II- Placebo Acupressure Bands | 51 |
|---|
No Nausea
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm I- Real Acupressure Bands | 19 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm II- Placebo Acupressure Bands | 28 | Not reported | Not reported | Not reported | Not reported |
|---|
Mild Nausea
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm I- Real Acupressure Bands | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm II- Placebo Acupressure Bands | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
Moderate Nausea
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm I- Real Acupressure Bands | 14 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm II- Placebo Acupressure Bands | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Severe Nausea
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm I- Real Acupressure Bands | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm II- Placebo Acupressure Bands | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 27
- group Id
- OG001
- value
- 27
- title
- No Nausea
- measurements
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 15
- title
- Mild Nausea
- measurements
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 13
- title
- Moderate Nausea
- measurements
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 13
- title
- Severe Nausea
- denoms
- counts
- group Id
- OG000
- value
- 75
- group Id
- OG001
- value
- 68
- units
- Participants
- title
- Day 1
- categories
- measurements
- group Id
- OG000
- value
- 28
- group Id
- OG001
- value
- 25
- title
- No Nausea
- measurements
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 20
- title
- Mild Nausea
- measurements
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 12
- title
- Moderate Nausea
- measurements
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 5
- title
- Severe Nausea
- denoms
- counts
- group Id
- OG000
- value
- 67
- group Id
- OG001
- value
- 62
- units
- Participants
- title
- Day 2
- categories
- measurements
- group Id
- OG000
- value
- 28
- group Id
- OG001
- value
- 33
- title
- No Nausea
- measurements
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 14
- title
- Mild Nausea
- measurements
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 7
- title
- Moderate Nausea
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 7
- title
- Severe Nausea
- denoms
- counts
- group Id
- OG000
- value
- 65
- group Id
- OG001
- value
- 61
- units
- Participants
- title
- Day 3
- categories
- measurements
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 28
- title
- No Nausea
- measurements
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 13
- title
- Mild Nausea
- measurements
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 3
- title
- Moderate Nausea
- measurements
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 7
- title
- Severe Nausea
- denoms
- counts
- group Id
- OG000
- value
- 56
- group Id
- OG001
- value
- 51
- units
- Participants
- title
- Days 4-7
- denoms
- counts
- group Id
- OG000
- value
- 83
- group Id
- OG001
- value
- 82
- units
- Participants
- description
- CIN = Chemotherapy-Induced Nausea. The delayed phase began at the end of the acute phase and continued until the first chemotherapy dose of the next chemotherapy block. Delayed Phase - Bands will continue to be worn for a maximum of 7 days or until the next chemotherapy cycle starts, whichever comes first. Nausea severity is defined as the maximum PeNAT (Pediatric Nausea Assessment Tool) score observed during each 24 hour period. The possible scores for the pediatric nausea assessment tool are no nausea, mild nausea, moderate nausea, severe nausea. Only patients who contributed at least 1 PeNAT score during the delayed phase were included.
- groups
- description
- Patients wear Sea-Band acupressure wristbands on each wrist beginning approximately 30 minutes prior to the first cisplatin-containing chemotherapy course and continually for 24 hours after the last chemotherapy dose (acute phase), and for a maximum of 7 days or until the next chemotherapy course starts (delayed phase). Patients are allowed to take bands off intermittently (up to 4 times a day, for no more than 15 minutes each time) to relieve pressure or to bathe. Patients also receive standard of care anti-emetic prophylaxis comprising granisetron, ondansetron, or dexamethasone during chemotherapy according to institutional or physician preference.
Real Acupressure Band: Acupressure wristband
- id
- OG000
- title
- Arm I- Real Acupressure Bands
- description
- Patients wear placebo wristbands on each wrist and receive standard of care anti-emetic prophylaxis during chemotherapy as patients in arm I.
Placebo Acupressure Band: Sham wristband
- id
- OG001
- title
- Arm II- Placebo Acupressure Bands
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The overall number of patients analyzed is 83 for Arm I and 82 for Arm II. Patients analyzed include the total number of patients that reported at least 1 PeNAT (Pediatric Nausea Assessment Tool) score on that day. The duration of the acute phase varied with chemotherapy regimen, according to study design. The number of patients receiving chemotherapy for longer than 3 days diminished each day, so days 4-7 were collapsed and considered a single day.
- reporting Status
- POSTED
- time Frame
- Maximum of 7 days after Acute Phase
- title
- Efficacy of Treatment on CIN During Delayed Phase of Chemotherapy
- type
- SECONDARY
- unit Of Measure
- Participants
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