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

Sponsor:	H. Lee Moffitt Cancer Center and Research Institute
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00429702

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 and Vomiting Unspecified Childhood Solid Tumor, Protocol Specific	Drug: dexamethasone Drug: diphenhydramine hydrochloride Drug: lorazepam Drug: ondansetron hydrochloride	Phase II

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double-Blind
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]

Resource links provided by NLM:

MedlinePlus related topics: Cancer Nausea and Vomiting

Drug Information available for: Dexamethasone Promethazine hydrochloride Diphenhydramine Promethazine Dexamethasone acetate Doxiproct plus Diphenhydramine citrate Ondansetron hydrochloride Ondansetron Diphenhydramine hydrochloride Lorazepam Dexamethasone Sodium Phosphate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

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 [ Designated as safety issue: No ]

Secondary Outcome Measures:

Efficacy of diphenhydramine hydrochloride, lorazepam, and dexamethasone in preventing CINV for 3 days after completion of the first course of emetogenic chemotherapy [ Designated as safety issue: No ]
Severity of CINV as measured by the Adapted Rhodes Index of Nausea, Vomiting, and Retching--Measured by Child/Parent questionnaire [ Designated as safety issue: No ]

Estimated Enrollment:	180
Study Start Date:	October 2007
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Experimental 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: dexamethasone Given IV Drug: diphenhydramine hydrochloride Given IV Drug: lorazepam Given IV Drug: ondansetron hydrochloride Given IV
Arm II: Active Comparator 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: dexamethasone Given IV Drug: ondansetron hydrochloride Given IV

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

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

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

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 5HT_3 antagonists
No concurrent enrollment on another investigational protocol involving a study agent that is provided under an IND

Contacts and Locations

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

Locations

United States, Florida
Arnold Palmer Hospital for Children
Orlando, Florida, United States, 32806
Children's Hospital of Southwest Florida
Fort Myers, Florida, United States, 33908
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

H. Lee Moffitt Cancer Center and Research Institute

National Cancer Institute (NCI)

Investigators

Study Chair:

Haydar Frangoul, MD

Vanderbilt-Ingram Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	H. Lee Moffitt Cancer Center and Research Institute at University of South Florida ( Jeffrey P. Krischer )
Study ID Numbers:	CDR0000527333, HLMCC-0503
Study First Received:	January 31, 2007
Last Updated:	August 25, 2009
ClinicalTrials.gov Identifier:	NCT00429702 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

nausea and vomiting
unspecified childhood solid tumor, protocol specific

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Dexamethasone
Neurotransmitter Agents
Vomiting
Signs and Symptoms, Digestive
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
GABA Modulators
Physiological Effects of Drugs
Psychotropic Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anesthetics
Antiemetics
Hormones
Lorazepam

Signs and Symptoms
Serotonin Antagonists
Promethazine
Sensory System Agents
Therapeutic Uses
Hypnotics and Sedatives
Antipruritics
Nausea
Ondansetron
Dermatologic Agents
Dexamethasone acetate
Tranquilizing Agents
Antineoplastic Agents, Hormonal
Gastrointestinal Agents
Histamine Agents

ClinicalTrials.gov processed this record on November 30, 2009