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Phase II Randomized Study of Diphenhydramine Hydrochloride, Lorazepam, and Dexamethasone for Chemotherapy-Induced Nausea and Vomiting in Pediatric Patients With Newly Diagnosed Cancer

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Diphenhydramine, Lorazepam, and Dexamethasone in Treating Nausea and Vomiting Caused By Chemotherapy in Young Patients With Newly Diagnosed Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase II Supportive care Completed 8 to 18 NCI HLMCC-0503
HLMCC 0503, NCT00429702

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.

Entry Criteria

Disease Characteristics:

Newly diagnosed cancer
- Chemotherapy naive

Scheduled to receive moderately or highly emetogenic chemotherapy as an inpatient

Scheduled for placement of a double-lumen catheter (to be used during chemotherapy treatment)

No CNS disease

Prior/Concurrent Therapy:

See Disease Characteristics
No prior chemotherapy
No prior stem cell transplantation
No other concurrent steroids (i.e., no steroids included in the chemotherapy regimen)
No other concurrent 5HT₃ antagonists
No concurrent enrollment on another investigational protocol involving a study agent that is provided under an IND

Patient Characteristics:

No contraindication to the use of dexamethasone (e.g., diabetes)
No hepatic and/or renal failure
No known allergy or hypersensitivity to any of the study medications
Not pregnant or nursing
Fertile patients must use effective contraception

Expected Enrollment

180

A total of 180 patients will be accrued for this study.

Outcomes

Primary Outcome(s)

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

Secondary Outcome(s)

Efficacy of diphenhydramine hydrochloride, lorazepam, and dexamethasone in preventing CINV for 3 days after completion of the first course of emetogenic chemotherapy
Severity of CINV as measured by the Adapted Rhodes Index of Nausea, Vomiting, and Retching--Measured by Child/Parent questionnaire

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.

Trial Contact Information

Trial Lead Organizations

H. Lee Moffitt Cancer Center CCOP Research Base

Haydar Frangoul, MD, Protocol chair
Ph: 615-936-1782; 800-811-8480
Email: haydar.frangoul@vanderbilt.edu

Registry Information

Official Title		Phase II Randomized, Double-Blinded Study of an Antiemetic Pump, Using Benadryl®, Avitan® and Decadron® (BAD), for Children Receiving Moderately or Highly Emetogenic Chemotherapy [BAD]

Trial Start Date		2007-10-24

Trial Completion Date		2009-08-20

Registered in ClinicalTrials.gov		NCT00429702

Date Submitted to PDQ		2006-12-15

Information Last Verified		2009-06-07

NCI Grant/Contract Number		CA76292

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.