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
  Purpose

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.


Condition Intervention Phase
Nausea
Vomiting
Unspecified Childhood Solid Tumor, Protocol Specific
Drug: Decadron®
Drug: Benadryl®
Drug: Ativan®
Drug: ondansetron hydrochloride
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 7
Study Start Date: October 2007
Study Completion Date: November 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
Drug: Decadron®
Given IV
Other Name: dexamethasone
Drug: ondansetron hydrochloride
Given IV
Other Names:
  • Zofran
  • Ondisolv

Detailed 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.

  Eligibility

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00429702

Locations
United States, Florida
Children's Hospital of Southwest Florida
Fort Myers, Florida, United States, 33908
Arnold Palmer Hospital for Children
Orlando, Florida, United States, 32806
St. Joseph's Children's Hospital of Tampa
Tampa, Florida, United States, 33677-4227
United States, Mississippi
University of Mississippi Cancer Clinic
Jackson, Mississippi, United States, 39216-4505
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
United States, Texas
CHRISTUS Santa Rosa Children's Hospital
San Antonio, Texas, United States, 78207
Puerto Rico
San Jorge Children's Hospital
Santurce, Puerto Rico, 00912
Sponsors and Collaborators
University of South Florida
Investigators
Study Chair: Haydar Frangoul, MD Vanderbilt-Ingram Cancer Center
  More Information

No publications provided

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT00429702     History of Changes
Other Study ID Numbers: SCUSF 0503, SCUSF-0503, HLMCC-0503, U10CA081920
Study First Received: January 31, 2007
Results First Received: March 24, 2014
Last Updated: June 26, 2014
Health Authority: United States: Data and Safety Monitoring Board
United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of South Florida:
nausea
vomiting
emetic chemotherapy
unspecified childhood solid tumor, protocol specific

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Dexamethasone acetate
Dexamethasone
Ondansetron
Diphenhydramine
Lorazepam
Dexamethasone 21-phosphate
BB 1101
Promethazine
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antipruritics

ClinicalTrials.gov processed this record on September 22, 2014