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

Condition(s) targeted: Nausea; Vomiting; Unspecified Childhood Solid Tumor, Protocol Specific

Intervention: Decadron® (Drug); Benadryl® (Drug); Ativan® (Drug); ondansetron hydrochloride (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: University of South Florida

Official(s) and/or principal investigator(s):
Haydar Frangoul, MD, Study Chair, Affiliation: Vanderbilt-Ingram Cancer Center

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.

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

Primary outcome: Proportion of Patients Requiring Rescue Medication for Breakthrough Nausea or Emesis During Inpatient Chemotherapy

Secondary outcome: Proportion of Patients Requiring Rescue Medication for Breakthrough Nausea or Emesis After Completion of the First Course of Emetogenic Chemotherapy

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.

Minimum age: 8 Years. Maximum age: 18 Years. Gender(s): Both.

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

San Jorge Children's Hospital, Santurce 00912, Puerto Rico

Children's Hospital of Southwest Florida, Fort Myers, Florida 33908, United States

Arnold Palmer Hospital for Children, Orlando, Florida 32806, United States

St. Joseph's Children's Hospital of Tampa, Tampa, Florida 33677-4227, United States

University of Mississippi Cancer Clinic, Jackson, Mississippi 39216-4505, United States

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee 37232-6838, United States

CHRISTUS Santa Rosa Children's Hospital, San Antonio, Texas 78207, United States

Starting date: October 2007
Last updated: June 26, 2014