NCT01346267 · OUTCOME
Comparison of Control of CIV During the Acute and 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 14 days
What was measured
CIV = Chemotherapy-Induced Vomiting. Total Duration of Study includes both acute and delayed phases. Acute Phase - bands will be worn on each day of the chemotherapy course and for 24 hours after the last chemotherapy dose. Delayed Phase - Bands will continue to be worn for a maximum of 7 days or until the next chemotherapy cycle starts, whichever comes first. A breakthrough antiemetic agent is defined as a medication that is administered or taken in order to relieve or treat (rather than prevent) nausea or vomiting. An antiemetic agent that is prescribed and/or administered on an "as needed" basis is considered to be a breakthrough antiemetic. Complete CIV Control during the acute and delayed phases is defined as no emetic episodes and no breakthrough anti-emetic agents administered during the phase of interest. Partial CIV Control is defined as 1 or 2 emetic episodes in any 24 ho
Analysis population: The overall number of participants analyzed is 83 participants in Arm I and 82 participants in Arm II. In the acute phase, 165 patients provided at least 1 PeNAT (Pediatric Nausea Assessment Tool) score. In the delayed phase, 144 patients contributed at least 1 PeNAT score.
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
Acute Phase
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm I- Real Acupressure Bands | 83 |
|---|
| Arm II- Placebo Acupressure Bands | 82 |
|---|
Complete CIV Control
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm I- Real Acupressure Bands | 17 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm II- Placebo Acupressure Bands | 19 | Not reported | Not reported | Not reported | Not reported |
|---|
Partial CIV Control
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm I- Real Acupressure Bands | 43 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm II- Placebo Acupressure Bands | 48 | Not reported | Not reported | Not reported | Not reported |
|---|
Failed CIV Control
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm I- Real Acupressure Bands | 23 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm II- Placebo Acupressure Bands | 15 | Not reported | Not reported | Not reported | Not reported |
|---|
Delayed Phase
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm I- Real Acupressure Bands | 75 |
|---|
| Arm II- Placebo Acupressure Bands | 69 |
|---|
Complete CIV Control
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm I- Real Acupressure Bands | 35 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm II- Placebo Acupressure Bands | 31 | Not reported | Not reported | Not reported | Not reported |
|---|
Partial CIV Control
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm I- Real Acupressure Bands | 29 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm II- Placebo Acupressure Bands | 28 | Not reported | Not reported | Not reported | Not reported |
|---|
Failed CIV Control
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm I- Real Acupressure Bands | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm II- Placebo Acupressure Bands | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 19
- title
- Complete CIV Control
- measurements
- group Id
- OG000
- value
- 43
- group Id
- OG001
- value
- 48
- title
- Partial CIV Control
- measurements
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 15
- title
- Failed CIV Control
- denoms
- counts
- group Id
- OG000
- value
- 83
- group Id
- OG001
- value
- 82
- units
- Participants
- title
- Acute Phase
- categories
- measurements
- group Id
- OG000
- value
- 35
- group Id
- OG001
- value
- 31
- title
- Complete CIV Control
- measurements
- group Id
- OG000
- value
- 29
- group Id
- OG001
- value
- 28
- title
- Partial CIV Control
- measurements
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 10
- title
- Failed CIV Control
- denoms
- counts
- group Id
- OG000
- value
- 75
- group Id
- OG001
- value
- 69
- units
- Participants
- title
- Delayed Phase
- denoms
- counts
- group Id
- OG000
- value
- 83
- group Id
- OG001
- value
- 82
- units
- Participants
- description
- CIV = Chemotherapy-Induced Vomiting. Total Duration of Study includes both acute and delayed phases. Acute Phase - bands will be worn on each day of the chemotherapy course and for 24 hours after the last chemotherapy dose. Delayed Phase - Bands will continue to be worn for a maximum of 7 days or until the next chemotherapy cycle starts, whichever comes first. A breakthrough antiemetic agent is defined as a medication that is administered or taken in order to relieve or treat (rather than prevent) nausea or vomiting. An antiemetic agent that is prescribed and/or administered on an "as needed" basis is considered to be a breakthrough antiemetic. Complete CIV Control during the acute and delayed phases is defined as no emetic episodes and no breakthrough anti-emetic agents administered during the phase of interest. Partial CIV Control is defined as 1 or 2 emetic episodes in any 24 ho
- 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 participants analyzed is 83 participants in Arm I and 82 participants in Arm II. In the acute phase, 165 patients provided at least 1 PeNAT (Pediatric Nausea Assessment Tool) score. In the delayed phase, 144 patients contributed at least 1 PeNAT score.
- reporting Status
- POSTED
- time Frame
- Maximum of 14 days
- title
- Comparison of Control of CIV During the Acute and Delayed Phase of Chemotherapy
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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