Clinical Trial: Acupressure in Controlling Nausea in Young Patients Receiving Highly Emetogenic Chemotherapy
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Randomized Controlled Trial of Acupressure to Control Chemotherapy-Induced Nausea (CIN) in Children Receiving Highly Emetogenic Chemotherapy
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 Summary:
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 ch
Sponsor: University of South Florida
Current Primary Outcome: Control of CIN during acute phase of chemotherapy [ Time Frame: Each day of Chemotherapy course. Maximum of 7 days ]
Acute Phase - bands will be worn on each day of the chemotherapy course and for 24 hours after the last chemotherapy dose
Original Primary Outcome: Control of CIN during acute phase of chemotherapy
Current Secondary Outcome:
- Control of CIN during delayed phase of chemotherapy [ Time Frame: Maximum of 7 days after Acute Phase ]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 ]
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.
Original Secondary Outcome:
- Control of CIN during delayed phase of chemotherapy
- Comparison of CIN during acute and delayed phase of chemotherapy
Information By: University of South Florida
Dates:
Date Received: April 29, 2011
Date Started: May 2011
Date Completion: May 2017
Last Updated: March 24, 2017
Last Verified: March 2017
- Control of CIN during delayed phase of chemotherapy [ Time Frame: Maximum of 7 days after Acute Phase ]
