Trial Outcomes & Findings for Acupressure in Controlling Nausea in Young Patients Receiving Highly Emetogenic Chemotherapy (NCT NCT01346267)
NCT ID: NCT01346267
Last Updated: 2021-08-18
Results Overview
CIN = Chemotherapy-Induced Nausea. The acute phase began with administration of the first chemotherapy dose of a chemotherapy block and continued until 24 hours after administration of the last chemotherapy dose of the block. Acute Phase - bands will be worn on each day of the chemotherapy course and for 24 hours after the last chemotherapy dose. Nausea severity during the acute phase of chemotherapy 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 acute phase were included. The duration of the acute phase varied with chemotherapy regimen, according to study design.
COMPLETED
NA
187 participants
Each day of Chemotherapy course. Maximum of 7 days
2021-08-18
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
93
|
94
|
|
Overall Study
COMPLETED
|
70
|
67
|
|
Overall Study
NOT COMPLETED
|
23
|
27
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acupressure in Controlling Nausea in Young Patients Receiving Highly Emetogenic Chemotherapy
Baseline characteristics by cohort
| Measure |
Arm I- Real Acupressure Bands
n=83 Participants
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
n=82 Participants
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
|
Total
n=165 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
12.5 Years
STANDARD_DEVIATION 4.3 • n=5 Participants
|
12.9 Years
STANDARD_DEVIATION 4.2 • n=7 Participants
|
12.7 Years
STANDARD_DEVIATION 4.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Diagnosis
Osteosarcoma
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Diagnosis
Hodgkin Lymphoma
|
20 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Diagnosis
Ewing Sarcoma
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Diagnosis
Other
|
38 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Each day of Chemotherapy course. Maximum of 7 daysPopulation: 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.
CIN = Chemotherapy-Induced Nausea. The acute phase began with administration of the first chemotherapy dose of a chemotherapy block and continued until 24 hours after administration of the last chemotherapy dose of the block. Acute Phase - bands will be worn on each day of the chemotherapy course and for 24 hours after the last chemotherapy dose. Nausea severity during the acute phase of chemotherapy 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 acute phase were included. The duration of the acute phase varied with chemotherapy regimen, according to study design.
Outcome measures
| Measure |
Arm I- Real Acupressure Bands
n=83 Participants
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
n=82 Participants
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
|
|---|---|---|
|
Efficacy of Treatment on CIN During Acute Phase of Chemotherapy
Day 1 · No Nausea
|
37 Participants
|
41 Participants
|
|
Efficacy of Treatment on CIN During Acute Phase of Chemotherapy
Day 1 · Mild Nausea
|
17 Participants
|
8 Participants
|
|
Efficacy of Treatment on CIN During Acute Phase of Chemotherapy
Day 1 · Moderate Nausea
|
16 Participants
|
19 Participants
|
|
Efficacy of Treatment on CIN During Acute Phase of Chemotherapy
Day 1 · Severe Nausea
|
12 Participants
|
12 Participants
|
|
Efficacy of Treatment on CIN During Acute Phase of Chemotherapy
Day 2 · No Nausea
|
17 Participants
|
15 Participants
|
|
Efficacy of Treatment on CIN During Acute Phase of Chemotherapy
Day 2 · Mild Nausea
|
23 Participants
|
27 Participants
|
|
Efficacy of Treatment on CIN During Acute Phase of Chemotherapy
Day 2 · Moderate Nausea
|
24 Participants
|
20 Participants
|
|
Efficacy of Treatment on CIN During Acute Phase of Chemotherapy
Day 2 · Severe Nausea
|
16 Participants
|
18 Participants
|
|
Efficacy of Treatment on CIN During Acute Phase of Chemotherapy
Day 3 · No Nausea
|
13 Participants
|
16 Participants
|
|
Efficacy of Treatment on CIN During Acute Phase of Chemotherapy
Day 3 · Mild Nausea
|
19 Participants
|
17 Participants
|
|
Efficacy of Treatment on CIN During Acute Phase of Chemotherapy
Day 3 · Moderate Nausea
|
18 Participants
|
21 Participants
|
|
Efficacy of Treatment on CIN During Acute Phase of Chemotherapy
Day 3 · Severe Nausea
|
20 Participants
|
10 Participants
|
|
Efficacy of Treatment on CIN During Acute Phase of Chemotherapy
Days 4-7 · No Nausea
|
13 Participants
|
16 Participants
|
|
Efficacy of Treatment on CIN During Acute Phase of Chemotherapy
Days 4-7 · Mild Nausea
|
10 Participants
|
12 Participants
|
|
Efficacy of Treatment on CIN During Acute Phase of Chemotherapy
Days 4-7 · Moderate Nausea
|
11 Participants
|
10 Participants
|
|
Efficacy of Treatment on CIN During Acute Phase of Chemotherapy
Days 4-7 · Severe Nausea
|
16 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Maximum of 7 days after Acute PhasePopulation: 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.
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.
Outcome measures
| Measure |
Arm I- Real Acupressure Bands
n=83 Participants
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
n=82 Participants
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
|
|---|---|---|
|
Efficacy of Treatment on CIN During Delayed Phase of Chemotherapy
Day 2 · No Nausea
|
28 Participants
|
25 Participants
|
|
Efficacy of Treatment on CIN During Delayed Phase of Chemotherapy
Day 2 · Mild Nausea
|
15 Participants
|
20 Participants
|
|
Efficacy of Treatment on CIN During Delayed Phase of Chemotherapy
Day 2 · Moderate Nausea
|
15 Participants
|
12 Participants
|
|
Efficacy of Treatment on CIN During Delayed Phase of Chemotherapy
Day 2 · Severe Nausea
|
9 Participants
|
5 Participants
|
|
Efficacy of Treatment on CIN During Delayed Phase of Chemotherapy
Day 3 · No Nausea
|
28 Participants
|
33 Participants
|
|
Efficacy of Treatment on CIN During Delayed Phase of Chemotherapy
Day 3 · Mild Nausea
|
21 Participants
|
14 Participants
|
|
Efficacy of Treatment on CIN During Delayed Phase of Chemotherapy
Day 3 · Moderate Nausea
|
12 Participants
|
7 Participants
|
|
Efficacy of Treatment on CIN During Delayed Phase of Chemotherapy
Day 3 · Severe Nausea
|
4 Participants
|
7 Participants
|
|
Efficacy of Treatment on CIN During Delayed Phase of Chemotherapy
Days 4-7 · No Nausea
|
19 Participants
|
28 Participants
|
|
Efficacy of Treatment on CIN During Delayed Phase of Chemotherapy
Days 4-7 · Mild Nausea
|
13 Participants
|
13 Participants
|
|
Efficacy of Treatment on CIN During Delayed Phase of Chemotherapy
Days 4-7 · Moderate Nausea
|
14 Participants
|
3 Participants
|
|
Efficacy of Treatment on CIN During Delayed Phase of Chemotherapy
Days 4-7 · Severe Nausea
|
10 Participants
|
7 Participants
|
|
Efficacy of Treatment on CIN During Delayed Phase of Chemotherapy
Day 1 · No Nausea
|
27 Participants
|
27 Participants
|
|
Efficacy of Treatment on CIN During Delayed Phase of Chemotherapy
Day 1 · Mild Nausea
|
19 Participants
|
15 Participants
|
|
Efficacy of Treatment on CIN During Delayed Phase of Chemotherapy
Day 1 · Moderate Nausea
|
19 Participants
|
13 Participants
|
|
Efficacy of Treatment on CIN During Delayed Phase of Chemotherapy
Day 1 · Severe Nausea
|
10 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Maximum of 14 daysPopulation: 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.
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
Outcome measures
| Measure |
Arm I- Real Acupressure Bands
n=83 Participants
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
n=82 Participants
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
|
|---|---|---|
|
Comparison of Control of CIV During the Acute and Delayed Phase of Chemotherapy
Acute Phase · Complete CIV Control
|
17 Participants
|
19 Participants
|
|
Comparison of Control of CIV During the Acute and Delayed Phase of Chemotherapy
Acute Phase · Partial CIV Control
|
43 Participants
|
48 Participants
|
|
Comparison of Control of CIV During the Acute and Delayed Phase of Chemotherapy
Acute Phase · Failed CIV Control
|
23 Participants
|
15 Participants
|
|
Comparison of Control of CIV During the Acute and Delayed Phase of Chemotherapy
Delayed Phase · Complete CIV Control
|
35 Participants
|
31 Participants
|
|
Comparison of Control of CIV During the Acute and Delayed Phase of Chemotherapy
Delayed Phase · Partial CIV Control
|
29 Participants
|
28 Participants
|
|
Comparison of Control of CIV During the Acute and Delayed Phase of Chemotherapy
Delayed Phase · Failed CIV Control
|
11 Participants
|
10 Participants
|
Adverse Events
Arm I- Real Acupressure Bands
Arm II- Placebo Acupressure Bands
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Thomas W. McLean, MD
Wake Forest University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place