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

University of South Florida

Status and phase: Terminated; Phase 2

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

Treatments: Drug: Ativan®; Drug: ondansetron hydrochloride; Drug: Benadryl®; Drug: Decadron®

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00429702

HLMCC-0503 (Other Identifier)

U10CA081920 (U.S. NIH Grant/Contract)

SCUSF-0503 (Other Identifier)

SCUSF 0503

Details and patient eligibility

About

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.

Full 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, 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.

Enrollment: 7 patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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7 participants in 2 patient groups

Benadryl® Ativan® Decadron® (BAD) Pump

Experimental group

Description:

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.

Treatment:

Drug: Benadryl®

Drug: Decadron®

Drug: ondansetron hydrochloride

Drug: Ativan®

Control Arm Saline

Active Comparator group

Description:

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.

Treatment:

Drug: Decadron®

Drug: ondansetron hydrochloride