Clinical trial NCT00429702: Diphenhydramine, Lorazepam, and Dexamethasone in Treating Nausea and Vomiting Caused By Chemotherapy
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Nausea
Vomiting
Unspecified Childhood Solid Tumor, Protocol Specific
Keywords: nausea
vomiting
emetic chemotherapy
unspecified childhood solid tumor, protocol specific
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-02-01
Enrollment: 7
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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 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

Primary outcomes:
measure: Proportion of Patients Requiring Rescue Medication for Breakthrough Nausea or Emesis During Inpatient Chemotherapy
timeFrame: during in-patient cycle of chemotherapy, up to 4 days
Secondary outcomes:
measure: Proportion of Patients Requiring Rescue Medication for Breakthrough Nausea or Emesis After Completion of the First Course of Emetogenic Chemotherapy
timeFrame: 3 days of following completion of first chemotherapy cycle
Other outcomes:
Locations:
city: Fort Myers
country: United States
facility: Children's Hospital of Southwest Florida
state: Florida
city: Orlando
country: United States
facility: Arnold Palmer Hospital for Children
state: Florida
city: Tampa
country: United States
facility: St. Joseph's Children's Hospital of Tampa
state: Florida
city: Jackson
country: United States
facility: University of Mississippi Cancer Clinic
state: Mississippi
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
city: San Antonio
country: United States
facility: CHRISTUS Santa Rosa Children's Hospital
state: Texas
city: Santurce
country: Puerto Rico
facility: San Jorge Children's Hospital
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Haydar Frangoul, MD
role: STUDY_CHAIR
References: