Spots Global Cancer Trial Database for Acupressure in Controlling Nausea in Young Patients Receiving Highly Emetogenic Chemotherapy
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Trial Identification
Brief Title: Acupressure in Controlling Nausea in Young Patients Receiving Highly Emetogenic Chemotherapy
Official Title: Randomized Controlled Trial of Acupressure to Control Chemotherapy-Induced Nausea (CIN) in Children Receiving Highly Emetogenic Chemotherapy
Study ID: NCT01346267
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.
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.
Keywords
Eligibility
Minimum Age: 4 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, 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, Saint 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
Contact Details
Name: Thomas Williams McLean, MD
Affiliation: Wake Forest University Health Sciences
Role: STUDY_CHAIR
Name: Lee Dupuis, PhD
Affiliation: The Hospital for Sick Children
Role: STUDY_CHAIR
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