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

This study has been terminated.
(Closed due to poor accrual and lack of feasibility to finish study per DSMB)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT00429702
First received: January 31, 2007
Last updated: June 26, 2014
Last verified: June 2014

January 31, 2007
June 26, 2014
October 2007
August 2009   (final data collection date for primary outcome measure)
Proportion of Patients Requiring Rescue Medication for Breakthrough Nausea or Emesis During Inpatient Chemotherapy [ Time Frame: during in-patient cycle of chemotherapy, up to 4 days ] [ Designated as safety issue: No ]
Rescue medication is any medication administered by the treating team to control breakthrough nausea or emesis. Rescue medications were used to treat any patient who has enough symptoms requiring additional therapy. All patients were instructed to first use the push button on the pump. On-demand administration of study agent via the patient-controlled infusion pump will not be considered rescue therapy - it is part of the antiemetic treatment regimen. If on-demand administration is not successful in controlling the patient's symptoms, then as-needed rescue medications are to be administered. The treating staff will administer additional (as needed) doses of intravenous antiemetics, depending on the institutional preference.
Efficacy of diphenhydramine hydrochloride, lorazepam, and dexamethasone in preventing chemotx-induced nausea and vomiting (CINV) as measured by proportion of patients requiring rescue medication for breakthrough nausea or emesis during chemotx
Complete list of historical versions of study NCT00429702 on ClinicalTrials.gov Archive Site
Proportion of Patients Requiring Rescue Medication for Breakthrough Nausea or Emesis After Completion of the First Course of Emetogenic Chemotherapy [ Time Frame: 3 days of following completion of first chemotherapy cycle ] [ Designated as safety issue: No ]
CINV will be determined based on the number of rescue medications used during the 3 days following completion of chemotherapy cycle. Rescue medication is any medication administered by the treating team to control breakthrough nausea or emesis. Rescue medications were used to treat any patient who has enough symptoms requiring additional therapy. All patients were instructed to first use the push button on the pump. On-demand administration of study agent via the patient-controlled infusion pump will not be considered rescue therapy - it is part of the antiemetic treatment regimen. If on-demand administration is not successful in controlling the patient's symptoms, then as-needed rescue medications are to be administered. The treating staff will administer additional (as needed) doses of intravenous antiemetics, depending on the institutional preference.
  • 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
Not Provided
Not Provided
 
Diphenhydramine, Lorazepam, and Dexamethasone in Treating Nausea and Vomiting Caused By Chemotherapy
Phase II Randomized, Double-Blinded Study of an Antiemetic Pump, Using Benadryl®, Avitan® and Decadron® (BAD), for Children Receiving Moderately or Highly Emetogenic Chemotherapy

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
  • Nausea
  • Vomiting
  • Unspecified Childhood Solid Tumor, Protocol Specific
  • Drug: Decadron®
    Given IV
    Other Name: dexamethasone
  • Drug: Benadryl®
    Given IV
    Other Name: diphenhydramine hydrochloride
  • Drug: Ativan®
    Given IV
    Other Name: lorazepam
  • Drug: ondansetron hydrochloride
    Given IV
    Other Names:
    • Zofran
    • Ondisolv
  • Experimental: Benadryl® Ativan® Decadron® (BAD) Pump
    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.
    Interventions:
    • Drug: Decadron®
    • Drug: Benadryl®
    • Drug: Ativan®
    • Drug: ondansetron hydrochloride
  • Active Comparator: Control Arm Saline
    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.
    Interventions:
    • Drug: Decadron®
    • Drug: ondansetron hydrochloride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
7
November 2009
August 2009   (final data collection date for primary outcome measure)

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
Both
8 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00429702
SCUSF 0503, SCUSF-0503, HLMCC-0503, U10CA081920
Yes
University of South Florida
University of South Florida
National Cancer Institute (NCI)
Study Chair: Haydar Frangoul, MD Vanderbilt-Ingram Cancer Center
University of South Florida
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP