Status:
TERMINATED
Diphenhydramine, Lorazepam, and Dexamethasone in Treating Nausea and Vomiting Caused By Chemotherapy
Lead Sponsor:
University of South Florida
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Nausea
Vomiting
Eligibility:
All Genders
8-18 years
Phase:
PHASE2
Brief Summary
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, a...
Detailed Description
OBJECTIVES: Primary * Compare the degree of chemotherapy-induced nausea and vomiting (CINV) in pediatric patients with newly diagnosed cancer treated with diphenhydramine hydrochloride, lorazepam, a...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00429702
Start Date
October 1 2007
End Date
November 1 2009
Last Update
July 25 2014
Active Locations (7)
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1
Children's Hospital of Southwest Florida
Fort Myers, Florida, United States, 33908
2
Arnold Palmer Hospital for Children
Orlando, Florida, United States, 32806
3
St. Joseph's Children's Hospital of Tampa
Tampa, Florida, United States, 33677-4227
4
University of Mississippi Cancer Clinic
Jackson, Mississippi, United States, 39216-4505