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

• Status: Terminated
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

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, 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of South Florida
• Collaborator: National Cancer Institute (NCI)
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Diphenhydramine; Lorazepam; Ondansetron; Promethazine

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