Phase II Randomized, Double-Blinded Study of an Antiemetic Pump, Using Benadryl®, Avitan® and Decadron® (BAD), for Children Receiving Moderately or Highly Emetogenic Chemotherapy
- Compare the degree of chemotherapy-induced nausea and vomiting (CINV) in pediatric
patients with newly diagnosed cancer treated with diphenhydramine hydrochloride,
lorazepam, and dexamethasone vs standard antiemetic therapy during the first course of
- Compare the degree of CINV during the first 3 days after completion of the first course
of emetogenic chemotherapy in patients treated with these antiemetic regimens.
OUTLINE: This is a randomized, prospective, double-blind, multicenter study. Patients are
stratified according to the emetogenic potential of their chemotherapy regimen (high vs
moderate). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive ondansetron hydrochloride IV twice daily and saline IV twice
daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive
diphenhydramine hydrochloride, lorazepam, and dexamethasone by continuous infusion
- Arm II: Patients receive ondansetron hydrochloride IV twice daily and dexamethasone IV
twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also
receive saline by continuous infusion pump.
In both arms, treatment continues during the first course of chemotherapy. Patients may also
receive rescue antiemetic medication to control breakthrough nausea or emesis.
Patients and their parents complete the Adapted Rhodes Index of Nausea, Vomiting, and
Retching- Measured by Child/Parent questionnaire once before beginning chemotherapy, twice
daily during chemotherapy, and for 3 days after completion of chemotherapy.
PROJECTED ACCRUAL: A total of 180 patients will be accrued for this study.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Efficacy of diphenhydramine hydrochloride, lorazepam, & dexamethasone in preventing chemo-induced nausea & vomiting (CINV) as measured by proportion of patients requiring rescue medication for breakthrough nausea or emesis during inpatient chemotherapy
1 cycle of chemotherapy plus 3 days of follow-up
Haydar Frangoul, MD
Vanderbilt-Ingram Cancer Center
United States: Data and Safety Monitoring Board
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|
|Children's Hospital of Southwest Florida||Fort Myers, Florida 33908|
|University of Mississippi Cancer Clinic||Jackson, Mississippi 39216-4505|
|St. Joseph's Children's Hospital of Tampa||Tampa, Florida 33677-4227|
|CHRISTUS Santa Rosa Children's Hospital||San Antonio, Texas 78207|
|Arnold Palmer Hospital for Children||Orlando, Florida 32806|