Acupressure in Controlling Nausea in Young Patients Receiving Highly Emetogenic Chemotherapy (SCUSF1202)

This study is currently recruiting participants.
Verified December 2013 by University of South Florida
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT01346267
First received: April 29, 2011
Last updated: January 9, 2014
Last verified: December 2013
  Purpose

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 Intervention 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
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Randomized Controlled Trial of Acupressure to Control Chemotherapy-Induced Nausea (CIN) in Children Receiving Highly Emetogenic Chemotherapy

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • Control of CIN during acute phase of chemotherapy [ Time Frame: Each day of Chemotherapy course. Maximum of 7 days ] [ Designated as safety issue: No ]
    Acute Phase - bands will be worn on each day of the chemotherapy course and for 24 hours after the last chemotherapy dose


Secondary Outcome Measures:
  • Control of CIN during delayed phase of chemotherapy [ Time Frame: Maximum of 7 days after Acute Phase ] [ Designated as safety issue: No ]
    Delayed Phase - Bands will continue to be worn for a maximum of 7 days or until the next chemotherapy cycle starts, whichever comes first.

  • Comparison of CIN during acute and delayed phase of chemotherapy [ Time Frame: Maximum of 14 days ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 240
Study Start Date: May 2011
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: sham intervention

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

Ages Eligible for Study:   4 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01346267

  Hide Study Locations
Locations
United States, California
Miller Children's Hospital Not yet recruiting
Long Beach, California, United States, 90801
Contact: Devin Murphy, MSW    562-933-8626    dmurphy@memorialcare.org   
Principal Investigator: Amanda Termuhlen         
Childrens Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Leah Reichman    323-361-5973    lreichman@chla.usc.edu   
Principal Investigator: Kelley Haley         
United States, Connecticut
Connecticut Children's Medical Center Recruiting
Hartford, Connecticut, United States, 06106
Contact: Tiffany Ruiz    860-837-5877    truiz@ccmckids.org   
Principal Investigator: Michael Isakoff, MD         
United States, Delaware
A I duPont Hospital for Children Recruiting
Wilmington, Delaware, United States, 19803
Contact: Ande Wrightson, RN    302-651-5584      
United States, District of Columbia
Childrens National Medical Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Kelsey Hilton    202-476-4247      
United States, Florida
Children's Hospital of Southwest Florida at Lee Memorial Recruiting
Fort Myers, Florida, United States, 33901
Contact: Molly Arnstrom    239-343-6959      
Principal Investigator: Emad Salman, MD         
Nemours Children's Clinic Recruiting
Jacksonville, Florida, United States, 32207
Contact: Ingrid Ingram, RN, BSN    904-697-3985    iingram@nemours.org   
Principal Investigator: Eric Sandler, MD         
Nemours Children's Clinic - Orlando Recruiting
Orlando, Florida, United States, 32806
Contact: Kristen Gibbs    407-650-7230      
Principal Investigator: Ramamoorthy Nagasubramanian, MD         
Nemours Children's Clinic - Pensacola Recruiting
Pensacola, Florida, United States, 32504
Contact: Dannah McCormick    850-505-4794    Dannah.McCormick@nemours.org   
Principal Investigator: Jeffrey Schwartz, MD         
All Children's Hospital Recruiting
Saint Petersburg, Florida, United States, 33701
Contact: Ashley Repp    727-767-4784    AshleyRepp@allkids.org   
Principal Investigator: Gregory Hale, MD         
Tampa General Hospital Recruiting
Tampa, Florida, United States, 33606
Contact: Denise Fife, RN, CCRP    813-844-7829      
United States, Hawaii
Kapiolani Medical for Women and Children Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Annette Amiotte    808-983-6386    annette.amiotte@hawaiipacifichealth.org   
Principal Investigator: Robert Wilkinson, MD         
United States, Louisiana
Ochsner Clinic Foundation New Orleans Not yet recruiting
New Orleans, Louisiana, United States, 70121
Contact: Melissa Forschler, RN    504-842-3903    mforschler@ochsner.org   
Principal Investigator: Craig Lotterman, MD         
United States, Massachusetts
Dana Farber Cancer Institute at Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Michelle Ellis    617-632-4595      
Principal Investigator: Nicole Ullrich, MD PhD         
United States, New York
Columbia University Medical Center Recruiting
New York City, New York, United States, 10032
Contact: Margie Negron    212-305-8630      
Principal Investigator: Elena Ladas, PhD, RD         
United States, North Carolina
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157-1096
Contact: Graham Keyes    336-716-9027      
Principal Investigator: Thomas McLean, MD         
United States, Ohio
Mercy Children's Hospital Recruiting
Toledo, Ohio, United States, 43608
Contact: Trish Ahrens    419-251-8075      
Principal Investigator: Rama Jasty, MD         
United States, Oregon
Randall Children's Hospital at Legacy Emanuel Recruiting
Portland, Oregon, United States, 97227
Contact: Martha Rashko, CCRP    503-276-9376      
Principal Investigator: Janice F Olson, MD         
United States, Texas
CHRISTUS Santa Rosa Children's Hospital Recruiting
San Antonio, Texas, United States, 78229
Contact: Julie Garcia    210-567-7461    garciaj29@uthscsa.edu   
Principal Investigator: Anne-Marie Langevin, MD         
Scott & White Pediatrics Recruiting
Temple, Texas, United States, 76508
Contact: Niki Watson, CCRP    254-724-5079      
United States, Utah
Primary Children's Medical Center Recruiting
Salt Lake City, Utah, United States, 84113-1100
Contact: Jason Clawson, BA    801-662-4715    jason.clawson@hsc.utah.edu   
Principal Investigator: Phillip Barnette, MD         
Canada, Ontario
Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Entela Zaffino    416-813-5055      
Principal Investigator: Lillian Sung         
Principal Investigator: Lee Dupuis         
Sponsors and Collaborators
University of South Florida
Investigators
Study Chair: Thomas Williams McLean, MD Comprehensive Cancer Center of Wake Forest University
Study Chair: Lee Dupuis, MScPhm The Hospital for Sick Children
  More Information

Additional Information:
No publications provided

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT01346267     History of Changes
Other Study ID Numbers: SCUSF 1202, SCUSF-1202, Previously COG-ACCL1032, 5U10CA081920
Study First Received: April 29, 2011
Last Updated: January 9, 2014
Health Authority: United States: Data and Safety Monitoring Board
United States: Federal Government
United States: Institutional Review Board

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

Additional relevant MeSH terms:
Nausea
Nervous System Neoplasms
Vomiting
Central Nervous System Neoplasms
Signs and Symptoms, Digestive
Signs and Symptoms
Neoplasms by Site
Neoplasms
Nervous System Diseases
Emetics
Physiological Effects of Drugs
Pharmacologic Actions
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents

ClinicalTrials.gov processed this record on April 21, 2014