Diphenhydramine, Lorazepam, and Dexamethasone in Treating Nausea and Vomiting Caused By Chemotherapy

Stopped early · Phase 2

Conditions studied: Nausea, Vomiting, Unspecified Childhood Solid Tumor, Protocol Specific

In brief

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.

Key facts

Study ID

NCT00429702

Run by

University of South Florida

People needed

7

Starts

2007-10-01

Expected to finish

2009-11-01

Last updated by the study team

2014-07-25

Who can join

Age: 8 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 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

You may not qualify if…

• 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

Where it is running

• Children's Hospital of Southwest Florida — Fort Myers, Florida, United States
• Arnold Palmer Hospital for Children — Orlando, Florida, United States
• St. Joseph's Children's Hospital of Tampa — Tampa, Florida, United States
• University of Mississippi Cancer Clinic — Jackson, Mississippi, United States
• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
• CHRISTUS Santa Rosa Children's Hospital — San Antonio, Texas, United States
• San Jorge Children's Hospital — Santurce, Puerto Rico

Full record on ClinicalTrials.gov

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