Phase II Randomized, Double-Blinded Study of an Antiemetic Pump, Using Benadryl®, Avitan® and Decadron® (BAD), for Children Receiving Moderately or Highly Emetogenic Chemotherapy
8 Years
18 Years
Both
Nausea, Vomiting, Unspecified Childhood Solid Tumor, Protocol Specific
Trial Information
Phase II Randomized, Double-Blinded Study of an Antiemetic Pump, Using Benadryl®, Avitan® and Decadron® (BAD), for Children Receiving Moderately or Highly Emetogenic Chemotherapy
OBJECTIVES:
Primary
- 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
emetogenic chemotherapy.
Secondary
- 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
pump.
- 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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Outcome Measure:
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
Outcome Time Frame:
1 cycle of chemotherapy plus 3 days of follow-up
Safety Issue:
No
Principal Investigator
Haydar Frangoul, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Vanderbilt-Ingram Cancer Center
Authority:
United States: Data and Safety Monitoring Board
Study ID:
SCUSF 0503
NCT ID:
NCT00429702
Start Date:
October 2007
Completion Date:
November 2009
Related Keywords:
- Nausea
- Vomiting
- Unspecified Childhood Solid Tumor, Protocol Specific
- nausea
- vomiting
- emetic chemotherapy
- unspecified childhood solid tumor, protocol specific
- Nausea
- Vomiting
Name | Location |
|---|---|
| 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 |
