Acupressure in Controlling Nausea in Young Patients Receiving Highly Emetogenic Chemotherapy
NCT ID: NCT01346267
Last Updated: 2021-08-18
Study Results
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View full resultsBasic Information
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COMPLETED
NA
187 participants
INTERVENTIONAL
2011-05-31
2016-05-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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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
Interventions
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Real Acupressure Band
Acupressure wristband
Placebo Acupressure Band
Sham wristband
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
4 Years
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of South Florida
OTHER
Responsible Party
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Principal Investigators
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Thomas Williams McLean, MD
Role: STUDY_CHAIR
Wake Forest University Health Sciences
Lee Dupuis, PhD
Role: STUDY_CHAIR
The Hospital for Sick Children
Locations
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Miller Children's Hospital
Long Beach, California, United States
Childrens Hospital Los Angeles
Los Angeles, California, United States
Connecticut Children's Medical Center
Hartford, Connecticut, United States
A I duPont Hospital for Children
Wilmington, Delaware, United States
Childrens National Medical Center
Washington D.C., District of Columbia, United States
Children's Hospital of Southwest Florida at Lee Memorial
Fort Myers, Florida, United States
Nemours Children's Clinic
Jacksonville, Florida, United States
Palms West Hospital
Loxahatchee Groves, Florida, United States
Nemours Children's Clinic - Orlando
Orlando, Florida, United States
Nemours Children's Clinic - Pensacola
Pensacola, Florida, United States
All Children's Hospital
St. Petersburg, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Kapiolani Medical for Women and Children
Honolulu, Hawaii, United States
Ochsner Clinic Foundation New Orleans
New Orleans, Louisiana, United States
Dana Farber Cancer Institute at Boston Children's Hospital
Boston, Massachusetts, United States
Columbia University Medical Center
New York, New York, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Mercy Children's Hospital
Toledo, Ohio, United States
Randall Children's Hospital at Legacy Emanuel
Portland, Oregon, United States
Driscoll Children's Hospital
Corpus Christi, Texas, United States
CHRISTUS Santa Rosa Children's Hospital
San Antonio, Texas, United States
Methodist Healthcare System of San Antonio
San Antonio, Texas, United States
Scott & White Pediatrics
Temple, Texas, United States
Primary Children's Medical Center
Salt Lake City, Utah, United States
Hospital for Sick Children
Toronto, Ontario, Canada
Countries
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Other Identifiers
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SCUSF-1202
Identifier Type: OTHER
Identifier Source: secondary_id
Previously COG-ACCL1032
Identifier Type: OTHER
Identifier Source: secondary_id
SCUSF 1202
Identifier Type: -
Identifier Source: org_study_id
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