Acupressure in Controlling Nausea in Young Patients Receiving Highly Emetogenic Chemotherapy



Status:Completed
Conditions:Cancer, Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:4 - 18
Updated:10/29/2017
Start Date:May 2011
End Date:May 2016

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Randomized Controlled Trial of Acupressure to Control Chemotherapy-Induced Nausea (CIN) in Children Receiving Highly Emetogenic Chemotherapy

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.

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.

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
We found this trial at
25
sites
1717 South Orange Avenue # 100
Orlando, Florida 32806
(407) 650-7000
Principal Investigator: Ramamoorthy Nagasubramanian, MD
Phone: 407-650-7652
Nemours Children's Clinic - Orlando Located near downtown Orlando, Nemours Children’s Clinic, Orlando is a...
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3533 South Alameda Street
Corpus Christi, Texas 78411
(361) 694-5000
Principal Investigator: M. Chris Johnson, MD
Phone: 361-594-4439
Driscoll Children's Hospital Driscoll Children's Hospital was built because Clara Driscoll's will requested that a...
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Corpus Christi, TX
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282 Washington St
Hartford, Connecticut 06106
(860) 545-9000
Principal Investigator: Michael Isakoff, MD
Phone: 860-837-5877
Connecticut Children's Medical Center Connecticut Children’s Medical Center is a nationally recognized, 187-bed not-for-profit children’s...
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Hartford, CT
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807 Childrens Way
Jacksonville, Florida 32207
(904) 697-3600
Principal Investigator: Eric Sandler, MD
Phone: 904-697-3985
Nemours Children's Clinic At Nemours Children’s Clinic, Jacksonville, we've treated every child as we would...
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Jacksonville, FL
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Principal Investigator: David Freyer, MD
Phone: 323-361-5973
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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5153 North 9th Avenue
Pensacola, Florida 32504
(850) 505-4700
Principal Investigator: Jeffrey Schwartz, MD
Phone: 850-505-4794
Nemours Children's Clinic - Pensacola Nemours Children’s Clinic, Pensacola serves children and families in northwest...
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Pensacola, FL
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100 N Mario Capecchi Dr
Salt Lake City, Utah 84132
(801) 662-1000
Principal Investigator: Phillip Barnette, MD
Phone: 801-662-4715
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1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
Principal Investigator: Cameron Tebbi, MD
Phone: 813-844-7829
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
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Boston, Massachusetts 02115
Principal Investigator: Nicole Ullrich, MD PhD
Phone: 617-632-5376
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Fort Myers, Florida 33908
Principal Investigator: Emad Salman, MD
Phone: 239-343-6959
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Honolulu, Hawaii 96813
Principal Investigator: Robert Wilkinson, MD
Phone: 808-983-6386
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2801 Atlantic Ave
Long Beach, California 90806
(562) 933-5437
Principal Investigator: Amanda Termuhlen, MD
Phone: 562-933-8626
Miller Children's Hospital Miller Children
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13001 Southern Boulevard
Loxahatchee Groves, Florida 33470
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New Orleans, Louisiana 70121
Principal Investigator: Craig Lotterman, MD
Phone: 504-842-3903
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Portland, Oregon 97227
Principal Investigator: Janice F Olson, MD
Phone: 503-413-3498
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Saint Petersburg, Florida 33701
Principal Investigator: Gregory Hale, MD
Phone: 727-767-4784
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San Antonio, Texas 78207
Principal Investigator: Anne-Marie Langevin, MD
Phone: 210-567-7461
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San Antonio, Texas 78229
Principal Investigator: Robert Sanders, MD
Phone: 210-575-7863
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Temple, Texas 76508
Principal Investigator: Guy H Grayson, MD
Phone: 254-935-5185
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2213 Cherry Street
Toledo, Ohio 43608
(419) 251-8000
Principal Investigator: Rama Jasty, MD
Phone: 419-251-8075
Mercy Children's Hospital Mercy Children's Hospital is a regional resource for advanced pediatric care located...
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555 University Avenue
Toronto, Ontario M5G 1X8
Principal Investigator: Lillian Sung, MD
Phone: 416-813-4976
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Washington, D.C., District of Columbia
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Wilmington, Delaware 19803
Principal Investigator: E. Anders Kolb, MD
Phone: 302-651-5584
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Principal Investigator: Thomas McLean, MD
Phone: 336-716-9027
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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