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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00429702
Other study ID # SCUSF 0503
Secondary ID SCUSF-0503HLMCC-
Status Terminated
Phase Phase 2
First received January 31, 2007
Last updated June 26, 2014
Start date October 2007
Est. completion date November 2009

Study information

Verified date June 2014
Source University of South Florida
Contact n/a
Is FDA regulated No
Health authority United States: Data and Safety Monitoring BoardUnited States: Federal GovernmentUnited States: Food and Drug AdministrationUnited States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 7
Est. completion date November 2009
Est. primary completion date August 2009
Accepts healthy volunteers No
Gender Both
Age group 8 Years to 18 Years
Eligibility 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

Study Design

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


Related Conditions & MeSH terms

  • Nausea
  • Unspecified Childhood Solid Tumor, Protocol Specific
  • Vomiting

Intervention

Drug:
Decadron®
Given IV
Benadryl®
Given IV
Ativan®
Given IV
ondansetron hydrochloride
Given IV

Locations

Country Name City State
Puerto Rico San Jorge Children's Hospital Santurce
United States Children's Hospital of Southwest Florida Fort Myers Florida
United States University of Mississippi Cancer Clinic Jackson Mississippi
United States Vanderbilt-Ingram Cancer Center Nashville Tennessee
United States Arnold Palmer Hospital for Children Orlando Florida
United States CHRISTUS Santa Rosa Children's Hospital San Antonio Texas
United States St. Joseph's Children's Hospital of Tampa Tampa Florida

Sponsors (2)

Lead Sponsor Collaborator
University of South Florida National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of Patients Requiring Rescue Medication for Breakthrough Nausea or Emesis During Inpatient Chemotherapy 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. during in-patient cycle of chemotherapy, up to 4 days No
Secondary Proportion of Patients Requiring Rescue Medication for Breakthrough Nausea or Emesis After Completion of the First Course of Emetogenic Chemotherapy 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. 3 days of following completion of first chemotherapy cycle No
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