SCUSF1202: Acupressure in Controlling Nausea in Young Patients Receiving Highly Emetogenic Chemotherapy

• Sponsor: University of South Florida (Other)
• Overall Status: Completed
• CT.gov ID: NCT01346267
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 187
• Locations: 25
• Arms: 2
• Duration (Months): 60
• Patients Per Site: 7.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

RATIONALE: Acupressure wristbands may prevent or reduce nausea and caused by chemotherapy. It is not yet known whether standard care is more effective with or without acupressure wristbands in controlling acute and delayed nausea.

PURPOSE: This randomized phase III trial is studying how well acupressure wristbands work with or without standard care in controlling nausea in young patients receiving highly emetogenic chemotherapy.

Condition or Disease	Intervention/Treatment	Phase
Central Nervous System Tumor, Pediatric; Chemotherapy-induced Nausea and Vomiting; Unspecified Childhood Solid Tumor, Protocol Specific	Procedure: Real Acupressure Band; Procedure: Placebo Acupressure Band	N/A

Detailed Description

OBJECTIVES:

Primary

• To compare the control of chemotherapy-induced nausea (CIN) in the acute phase provided by a 5-HT3 antagonist combined with acupressure versus placebo acupressure in children 4 to 18 years of age being treated with chemotherapy including cisplatin ≥ 50 mg/m2/dose, ifosfamide plus etoposide/doxorubicin, or cyclophosphamide plus an anthracycline.

Secondary

• To compare the control of CIN in the delayed phase provided by a 5-HT3 antagonist combined with acupressure versus placebo acupressure in children 4 to 18 years of age being treated with chemotherapy including cisplatin ≥ 50 mg/m2/dose, ifosfamide plus etoposide/doxorubicin, or cyclophosphamide plus an anthracycline.

• To compare the control of chemotherapy-induced vomiting and retching (CIV) in the acute and delayed phases provided by a 5-HT3 antagonist combined with acupressure versus placebo acupressure in children 4 to 18 years of age being treated with chemotherapy including cisplatin ≥ 50 mg/m2/dose, ifosfamide plus etoposide/doxorubicin, or cyclophosphamide plus an anthracycline.

OUTLINE: This is a multicenter study. Patients are stratified according chemotherapy regimen and anti-emetic Regimen 5-HT3 agonists (ondansetron or granisetron.) Patients are randomized to 1 of 2 treatment arms.

• Arm I: 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.

• Arm II: Patients wear placebo wristbands on each wrist and receive standard of care anti-emetic prophylaxis during chemotherapy as patients in arm I.

Patients, parents, or guardians are instructed to complete an impatient and an outpatient diaries on nausea severity and the time of each emetic episode. Patients, parents, or guardians also complete a questionnaire about acupressure at the end of the study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 187 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• Official Title: Randomized Controlled Trial of Acupressure to Control Chemotherapy-Induced Nausea (CIN) in Children Receiving Highly Emetogenic Chemotherapy
• Study Start Date: May 1, 2011
• Actual Primary Completion Date: May 1, 2016
• Actual Study Completion Date: May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Procedure: Real Acupressure Band; Acupressure wristband
Sham Comparator: 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.	Procedure: Placebo Acupressure Band; Sham wristband; Other Names: sham intervention

Outcome Measures

Primary Outcome Measures

1. Efficacy of Treatment on CIN During Acute Phase of Chemotherapy [Each day of Chemotherapy course. Maximum of 7 days]

   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.

Secondary Outcome Measures

1. Efficacy of Treatment on CIN During Delayed Phase of Chemotherapy [Maximum of 7 days after Acute Phase]

   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.

2. Comparison of Control of CIV During the Acute and Delayed Phase of Chemotherapy [Maximum of 14 days]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

INCLUSION CRITERIA:

• 4 to 18 years of age, inclusive. The patient's cognitive ability must be considered by a parent or healthcare professional to be at least at a 4 year-old level.

• Newly diagnosed (i.e., not relapsed) with any malignancy.

• Patients are not required to be registered on a COG therapeutic trial.

• The patient's current chemotherapy treatment plan must include at least 1 course of

• cisplatin at ≥ 50 mg/m2/dose or

• ifosfamide plus etoposide or doxorubicin or

• cyclophosphamide plus an anthracycline.

• Patients may have previously received other chemotherapy.

• The patient's current treatment plan must include an anti-emetic regimen with either ondansetron or granisetron on a scheduled basis. Patients may also receive dexamethasone for antiemetic prophylaxis during the acute phase at the discretion of the treating physician. Patients ≥ 12 years old may also receive aprepitant in conjunction with dexamethasone for antiemetic prophylaxis at the discretion of the treating physician.

• Patients needing anti-emetic treatment for breakthrough nausea/vomiting may also receive anti-emetic agents on an as needed (PRN) basis.

• The patient (parent/guardian) must be English-speaking (i.e., able to read and speak in English) since the PeNAT has been validated only in English.

• All patients and/or their parents or legal guardians must sign a written informed consent (patient assent is also recommended when applicable according to each institution's policy).

EXCLUSION CRITERIA:

• Prior history of acupressure use.

• Scheduled use of antiemetic agents other than ondansetron, granisetron, dexamethasone or aprepitant. Patients may receive other antiemetic agents PRN for breakthrough nausea/vomiting but not on a scheduled basis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Miller Children's Hospital	Long Beach	California	United States	90801
2	Childrens Hospital Los Angeles	Los Angeles	California	United States	90027
3	Connecticut Children's Medical Center	Hartford	Connecticut	United States	06106
4	A I duPont Hospital for Children	Wilmington	Delaware	United States	19803
5	Childrens National Medical Center	Washington	District of Columbia	United States	20010
6	Children's Hospital of Southwest Florida at Lee Memorial	Fort Myers	Florida	United States	33901
7	Nemours Children's Clinic	Jacksonville	Florida	United States	32207
8	Palms West Hospital	Loxahatchee Groves	Florida	United States	33470
9	Nemours Children's Clinic - Orlando	Orlando	Florida	United States	32806
10	Nemours Children's Clinic - Pensacola	Pensacola	Florida	United States	32504
11	All Children's Hospital	Saint Petersburg	Florida	United States	33701
12	Tampa General Hospital	Tampa	Florida	United States	33606
13	Kapiolani Medical for Women and Children	Honolulu	Hawaii	United States	96813
14	Ochsner Clinic Foundation New Orleans	New Orleans	Louisiana	United States	70121
15	Dana Farber Cancer Institute at Boston Children's Hospital	Boston	Massachusetts	United States	02115
16	Columbia University Medical Center	New York	New York	United States	10032
17	Wake Forest University Health Sciences	Winston-Salem	North Carolina	United States	27157-1096
18	Mercy Children's Hospital	Toledo	Ohio	United States	43608
19	Randall Children's Hospital at Legacy Emanuel	Portland	Oregon	United States	97227
20	Driscoll Children's Hospital	Corpus Christi	Texas	United States	78411
21	CHRISTUS Santa Rosa Children's Hospital	San Antonio	Texas	United States	78229
22	Methodist Healthcare System of San Antonio	San Antonio	Texas	United States	78229
23	Scott & White Pediatrics	Temple	Texas	United States	76508
24	Primary Children's Medical Center	Salt Lake City	Utah	United States	84113-1100
25	Hospital for Sick Children	Toronto	Ontario	Canada	M5G 1X8

Sponsors and Collaborators

• University of South Florida
• National Cancer Institute (NCI)

Investigators

• Study Chair: Thomas Williams McLean, MD, Wake Forest University Health Sciences
• Study Chair: Lee Dupuis, PhD, The Hospital for Sick Children

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of South Florida
• ClinicalTrials.gov Identifier: NCT01346267
• Other Study ID Numbers: SCUSF 1202; SCUSF-1202; Previously COG-ACCL1032; 5U10CA081920
• First Posted: May 2, 2011
• Last Update Posted: Aug 18, 2021
• Last Verified: Oct 1, 2017

• Keywords provided by University of South Florida: nausea and vomiting; unspecified childhood solid tumor; childhood central nervous system embryonal tumor; childhood central nervous system germ cell tumor; childhood central nervous system germinoma; childhood central nervous system mixed germ cell tumor; childhood central nervous system teratoma; childhood central nervous system yolk sac tumor; childhood mixed glioma; childhood oligodendroglioma; untreated childhood brain stem glioma; untreated childhood visual pathway and hypothalamic glioma; untreated childhood visual pathway glioma; childhood high-grade cerebellar astrocytoma; childhood high-grade cerebral astrocytoma; childhood low-grade cerebellar astrocytoma; childhood low-grade cerebral astrocytoma; untreated childhood cerebellar astrocytoma; untreated childhood cerebral astrocytoma; untreated childhood subependymal giant cell astrocytoma; childhood ependymoblastoma; untreated childhood medulloblastoma; untreated childhood pineoblastoma; childhood choroid plexus tumor; childhood craniopharyngioma; childhood supratentorial ependymoma; childhood supratentorial primitive neuroectodermal tumor; childhood medulloepithelioma; childhood infratentorial ependymoma; newly diagnosed childhood ependymoma; childhood meningioma
• Additional relevant MeSH terms: Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Nausea; Vomiting

Study Results

Participant Flow

Arm/Group Title	Arm I- Real Acupressure Bands	Arm II- Placebo Acupressure Bands
Arm/Group 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	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
Period Title: Overall Study
STARTED	93	94
COMPLETED	70	67
NOT COMPLETED	23	27

Baseline Characteristics

Arm/Group Title	Arm I- Real Acupressure Bands	Arm II- Placebo Acupressure Bands	Total
Arm/Group 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	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 of all reporting groups
Overall Participants	83	82	165
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	12.5 (4.3)	12.9 (4.2)	12.7 (4.2)
Sex: Female, Male (Count of Participants)
Female	37 44.6%	32 39%	69 41.8%
Male	46 55.4%	50 61%	96 58.2%
Diagnosis (Count of Participants)
Osteosarcoma	16 19.3%	17 20.7%	33 20%
Hodgkin Lymphoma	20 24.1%	29 35.4%	49 29.7%
Ewing Sarcoma	9 10.8%	6 7.3%	15 9.1%
Other	38 45.8%	30 36.6%	68 41.2%

Outcome Measures

1. Primary Outcome

Title	Efficacy of Treatment on CIN During Acute Phase of Chemotherapy
Description	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.
Time Frame	Each day of Chemotherapy course. Maximum of 7 days

Outcome Measure Data

Analysis 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.

Arm/Group Title	Arm I- Real Acupressure Bands	Arm II- Placebo Acupressure Bands
Arm/Group 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	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
Measure Participants	83	82
No Nausea	37 44.6%	41 50%
Mild Nausea	17 20.5%	8 9.8%
Moderate Nausea	16 19.3%	19 23.2%
Severe Nausea	12 14.5%	12 14.6%
No Nausea	17 20.5%	15 18.3%
Mild Nausea	23 27.7%	27 32.9%
Moderate Nausea	24 28.9%	20 24.4%
Severe Nausea	16 19.3%	18 22%
No Nausea	13 15.7%	16 19.5%
Mild Nausea	19 22.9%	17 20.7%
Moderate Nausea	18 21.7%	21 25.6%
Severe Nausea	20 24.1%	10 12.2%
No Nausea	13 15.7%	16 19.5%
Mild Nausea	10 12%	12 14.6%
Moderate Nausea	11 13.3%	10 12.2%
Severe Nausea	16 19.3%	5 6.1%

2. Secondary Outcome

Title	Efficacy of Treatment on CIN During Delayed Phase of Chemotherapy
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.
Time Frame	Maximum of 7 days after Acute Phase

Outcome Measure Data

Analysis 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.

Arm/Group Title	Arm I- Real Acupressure Bands	Arm II- Placebo Acupressure Bands
Arm/Group 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	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
Measure Participants	83	82
No Nausea	27 32.5%	27 32.9%
Mild Nausea	19 22.9%	15 18.3%
Moderate Nausea	19 22.9%	13 15.9%
Severe Nausea	10 12%	13 15.9%
No Nausea	28 33.7%	25 30.5%
Mild Nausea	15 18.1%	20 24.4%
Moderate Nausea	15 18.1%	12 14.6%
Severe Nausea	9 10.8%	5 6.1%
No Nausea	28 33.7%	33 40.2%
Mild Nausea	21 25.3%	14 17.1%
Moderate Nausea	12 14.5%	7 8.5%
Severe Nausea	4 4.8%	7 8.5%
No Nausea	19 22.9%	28 34.1%
Mild Nausea	13 15.7%	13 15.9%
Moderate Nausea	14 16.9%	3 3.7%
Severe Nausea	10 12%	7 8.5%

3. Secondary Outcome

Title	Comparison of Control of CIV During the Acute and Delayed Phase of Chemotherapy
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
Time Frame	Maximum of 14 days

Outcome Measure Data

Analysis 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.

Arm/Group Title	Arm I- Real Acupressure Bands	Arm II- Placebo Acupressure Bands
Arm/Group 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	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
Measure Participants	83	82
Complete CIV Control	17 20.5%	19 23.2%
Partial CIV Control	43 51.8%	48 58.5%
Failed CIV Control	23 27.7%	15 18.3%
Complete CIV Control	35 42.2%	31 37.8%
Partial CIV Control	29 34.9%	28 34.1%
Failed CIV Control	11 13.3%	10 12.2%

Adverse Events

Time Frame	First application of wrist bands through 8 days after administration of the last chemotherapy dose of the cisplatin-containing course.
Adverse Event Reporting Description	Adverse events could spontaneously be communicated by the patient/family and/or elicited via the Final Questionnaire.
Arm/Group Title	Arm I- Real Acupressure Bands		Arm II- Placebo Acupressure Bands
Arm/Group 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		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
All Cause Mortality
	Arm I- Real Acupressure Bands		Arm II- Placebo Acupressure Bands
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/83 (0%)		0/82 (0%)
Serious Adverse Events
	Arm I- Real Acupressure Bands		Arm II- Placebo Acupressure Bands
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/83 (0%)		0/82 (0%)
Other (Not Including Serious) Adverse Events
	Arm I- Real Acupressure Bands		Arm II- Placebo Acupressure Bands
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/83 (0%)		0/82 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.