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

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

Intervention: dexamethasone (Drug); diphenhydramine hydrochloride (Drug); lorazepam (Drug); ondansetron hydrochloride (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: H. Lee Moffitt Cancer Center and Research Institute

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 [BAD]

Study design: Supportive Care, Randomized, Double-Blind

Primary outcome: 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

Secondary outcome:

Efficacy of diphenhydramine hydrochloride, lorazepam, and dexamethasone in preventing CINV for 3 days after completion of the first course of emetogenic chemotherapy

Severity of CINV as measured by the Adapted Rhodes Index of Nausea, Vomiting, and Retching--Measured by Child/Parent questionnaire

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:

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

San Jorge Children's Hospital, Santurce 00912, Puerto Rico; Recruiting
Luis A. Clavell, MD, Phone: 787-728-1575, Email: dmorales@sjcms.com

Arnold Palmer Hospital for Children, Orlando, Florida 32806, United States; Recruiting
Don E. Eslin, MD, Phone: 321-841-1633, Email: rebecca.martin@orhs.org

Children's Hospital of Southwest Florida, Fort Myers, Florida 33908, United States; Recruiting
Emad K. Salman, MD, Phone: 239-343-6959, Email: carolyn.bell@leememorial.org

St. Joseph's Children's Hospital of Tampa, Tampa, Florida 33677-4227, United States; Recruiting
Cameron K. Tebbi, MD, Phone: 813-870-4387, Email: pamela.neu@baycare.org

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: October 2007
Last updated: October 24, 2008