Nausea Clinical Trial
Official title:
Phase II Randomized, Double-Blinded Study of an Antiemetic Pump, Using Benadryl®, Avitan® and Decadron® (BAD), for Children Receiving Moderately or Highly Emetogenic Chemotherapy
RATIONALE: Diphenhydramine, lorazepam, and dexamethasone may help lessen or prevent nausea
and vomiting in patients treated with chemotherapy. It is not yet known whether
diphenhydramine, lorazepam, and dexamethasone are more effective than standard therapy in
treating nausea and vomiting caused by chemotherapy.
PURPOSE: This randomized phase II trial is studying diphenhydramine, lorazepam, and
dexamethasone to see how well they work compared with standard therapy in treating nausea
and vomiting caused by chemotherapy in young patients with newly diagnosed cancer.
Status | Terminated |
Enrollment | 7 |
Est. completion date | November 2009 |
Est. primary completion date | August 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 8 Years to 18 Years |
Eligibility |
INCLUSION CRITERIA: - = 8 years of age and < 19 years of age at the time of registration - Newly diagnosed with cancer - Chemotherapy naive - Scheduled to receive moderately or highly emetogenic chemotherapy (non-steroid containing regimen) as an in-patient. (Refer to Appendix IV. In multiple agent regimens, select the agent with the highest emetic potential.) - Scheduled for placement of IV accesses device(s) for treatment purposes (allowing a dedicated line for continuous infusion of study agent) - Not pregnant or lactating EXCLUSION CRITERIA: - Prior chemotherapy - Central Nervous System disease - Stem cell transplant while on-study - Out-patient chemotherapy - Steroids are included in their chemotherapy regimen - Contraindication to the use of dexamethasone (e.g. diabetes) - Hepatic and/or renal failure - Allergic to any of the study medications - Pregnant or lactating |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Puerto Rico | San Jorge Children's Hospital | Santurce | |
United States | Children's Hospital of Southwest Florida | Fort Myers | Florida |
United States | University of Mississippi Cancer Clinic | Jackson | Mississippi |
United States | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee |
United States | Arnold Palmer Hospital for Children | Orlando | Florida |
United States | CHRISTUS Santa Rosa Children's Hospital | San Antonio | Texas |
United States | St. Joseph's Children's Hospital of Tampa | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
University of South Florida | National Cancer Institute (NCI) |
United States, Puerto Rico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of Patients Requiring Rescue Medication for Breakthrough Nausea or Emesis During Inpatient Chemotherapy | Rescue medication is any medication administered by the treating team to control breakthrough nausea or emesis. Rescue medications were used to treat any patient who has enough symptoms requiring additional therapy. All patients were instructed to first use the push button on the pump. On-demand administration of study agent via the patient-controlled infusion pump will not be considered rescue therapy - it is part of the antiemetic treatment regimen. If on-demand administration is not successful in controlling the patient's symptoms, then as-needed rescue medications are to be administered. The treating staff will administer additional (as needed) doses of intravenous antiemetics, depending on the institutional preference. | during in-patient cycle of chemotherapy, up to 4 days | No |
Secondary | Proportion of Patients Requiring Rescue Medication for Breakthrough Nausea or Emesis After Completion of the First Course of Emetogenic Chemotherapy | CINV will be determined based on the number of rescue medications used during the 3 days following completion of chemotherapy cycle. Rescue medication is any medication administered by the treating team to control breakthrough nausea or emesis. Rescue medications were used to treat any patient who has enough symptoms requiring additional therapy. All patients were instructed to first use the push button on the pump. On-demand administration of study agent via the patient-controlled infusion pump will not be considered rescue therapy - it is part of the antiemetic treatment regimen. If on-demand administration is not successful in controlling the patient's symptoms, then as-needed rescue medications are to be administered. The treating staff will administer additional (as needed) doses of intravenous antiemetics, depending on the institutional preference. | 3 days of following completion of first chemotherapy cycle | No |
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