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Acupressure in Controlling Nausea in Young Patients Receiving Highly Emetogenic Chemotherapy

Information source: University of South Florida
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Central Nervous System Tumor, Pediatric; Chemotherapy-induced Nausea and Vomiting; Unspecified Childhood Solid Tumor, Protocol Specific

Intervention: Real Acupressure Band (Procedure); Placebo Acupressure Band (Procedure)

Phase: Phase 3

Status: Recruiting

Sponsored by: University of South Florida

Official(s) and/or principal investigator(s):
Thomas Williams McLean, MD, Study Chair, Affiliation: Comprehensive Cancer Center of Wake Forest University
Lee Dupuis, PhD, Study Chair, Affiliation: The Hospital for Sick Children

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Primary outcome: Control of CIN during acute phase of chemotherapy

Secondary outcome:

Control of CIN during delayed phase of chemotherapy

Comparison of CIN during acute and delayed phase of chemotherapy

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.

Eligibility

Minimum age: 4 Years. Maximum age: 18 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Miller Children's Hospital, Long Beach, California 90801, United States; Recruiting
Devin Murphy, MSW, Phone: 562-933-8626, Email: dmurphy@memorialcare.org
Amanda Termuhlen, MD, Principal Investigator

Childrens Hospital Los Angeles, Los Angeles, California 90027, United States; Recruiting
Diana Palma, Phone: 323-361-5973, Email: dpalma@chla.usc.edu
David Freyer, MD, Principal Investigator

Connecticut Children's Medical Center, Hartford, Connecticut 06106, United States; Recruiting
Tiffany Ruiz, Phone: 860-837-5877, Email: truiz@ccmckids.org
Michael Isakoff, MD, Principal Investigator

A I duPont Hospital for Children, Wilmington, Delaware 19803, United States; Recruiting
Ande Wrightson, RN, Phone: 302-651-5584, Email: andrea.wrightson@nemours.org
E. Anders Kolb, MD, Principal Investigator

Childrens National Medical Center, Washington, District of Columbia 20010, United States; Recruiting
Kelsey Hilton, Phone: 202-476-4247, Email: khilton@childrensnational.org
Jeffrey Dome, MD, PhD, Principal Investigator

Children's Hospital of Southwest Florida at Lee Memorial, Fort Myers, Florida 33901, United States; Recruiting
Molly Arnstrom, Phone: 239-343-6959, Email: molly.arnstrom@leememorial.org
Emad Salman, MD, Principal Investigator

Nemours Children's Clinic, Jacksonville, Florida 32207, United States; Recruiting
Ingrid Ingram, RN, BSN, Phone: 904-697-3985, Email: iingram@nemours.org
Eric Sandler, MD, Principal Investigator

Palms West Hospital, Loxahatchee, Florida 33470, United States; Recruiting
Patricia Swasey, MSN RN CPON, Phone: 561-791-8134, Email: patricia.swasey@hcahealthcare.com
Melissa Singer, MD MPH FAAP, Principal Investigator

Nemours Children's Clinic - Orlando, Orlando, Florida 32806, United States; Recruiting
Kristen Gibbs, Phone: 407-650-7652, Email: kbgibbs@nemours.org
Ramamoorthy Nagasubramanian, MD, Principal Investigator

Nemours Children's Clinic - Pensacola, Pensacola, Florida 32504, United States; Recruiting
Dannah McCormick, Phone: 850-505-4794, Email: Dannah.McCormick@nemours.org
Jeffrey Schwartz, MD, Principal Investigator

All Children's Hospital, Saint Petersburg, Florida 33701, United States; Recruiting
Ashley Repp, Phone: 727-767-4784, Email: AshleyRepp@allkids.org
Gregory Hale, MD, Principal Investigator

Tampa General Hospital, Tampa, Florida 33606, United States; Recruiting
Denise Fife, RN, CCRP, Phone: 813-844-7829, Email: dafife@tgh.org
Cameron Tebbi, MD, Principal Investigator

Kapiolani Medical for Women and Children, Honolulu, Hawaii 96813, United States; Recruiting
Gayle Kearney, Phone: 808-983-6386, Email: GayleK@Kapiolani.org
Robert Wilkinson, MD, Principal Investigator

Ochsner Clinic Foundation New Orleans, New Orleans, Louisiana 70121, United States; Recruiting
Melissa Forschler, RN, Phone: 504-842-3903, Email: mforschler@ochsner.org
Craig Lotterman, MD, Principal Investigator

Dana Farber Cancer Institute at Boston Children's Hospital, Boston, Massachusetts 02115, United States; Recruiting
Ahmed M Faisal, Phone: 617-632-5376, Email: Ahmed_Faisal@DFCI.Harvard.EDU
Nicole Ullrich, MD PhD, Principal Investigator

Columbia University Medical Center, New York City, New York 10032, United States; Recruiting
Margie Negron, Phone: 212-305-8630, Email: mn164@columbia.edu
Elena Ladas, PhD, RD, Principal Investigator

Wake Forest University Health Sciences, Winston-Salem, North Carolina 27157-1096, United States; Recruiting
Graham Keyes, Phone: 336-716-9027, Email: grkeyes@wakehealth.edu
Thomas McLean, MD, Principal Investigator

Mercy Children's Hospital, Toledo, Ohio 43608, United States; Recruiting
Trish Ahrens, Phone: 419-251-8075, Email: patricia_ahrens@mercy.com
Rama Jasty, MD, Principal Investigator

Hospital for Sick Children, Toronto, Ontario M5G 1X8, Canada; Recruiting
Rachel Alix, Phone: 416-813-4976, Email: Rachel.Alix@sickkids.ca
Lillian Sung, MD, Principal Investigator
Lee Dupuis, PhD, Principal Investigator

Randall Children's Hospital at Legacy Emanuel, Portland, Oregon 97227, United States; Recruiting
Martha Rashko, CCRP, Phone: 503-413-3498, Email: mraschko@lhs.org
Janice F Olson, MD, Principal Investigator

Driscoll Children's Hospital, Corpus Christi, Texas 78411, United States; Recruiting
Erin Richmond, RN, CRA, Phone: 361-594-4439, Email: erin.richmond@dchstx.org
M. Chris Johnson, MD, Principal Investigator

CHRISTUS Santa Rosa Children's Hospital, San Antonio, Texas 78229, United States; Recruiting
Julie Garcia, Phone: 210-567-7461, Email: garciaj29@uthscsa.edu
Anne-Marie Langevin, MD, Principal Investigator

Methodist Healthcare System of San Antonio, San Antonio, Texas 78229, United States; Recruiting
Candace Taylor, Phone: 210-575-7863, Email: candace.taylor@mhshealth.com
Robert Sanders, MD, Principal Investigator

Scott & White Pediatrics, Temple, Texas 76508, United States; Recruiting
Niki Watson, CCRP, Phone: 254-935-5185, Email: swatson@sw.org
Guy H Grayson, MD, Principal Investigator

Primary Children's Medical Center, Salt Lake City, Utah 84113-1100, United States; Recruiting
Jennifer Craig, Phone: 801-662-4715, Email: Jennifer.Craig@imail.org
Phillip Barnette, MD, Principal Investigator

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: May 2011
Last updated: July 7, 2015

Page last updated: August 23, 2015

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