Clinical trial · Interventional
Diphenhydramine, Lorazepam, and Dexamethasone in Treating Nausea and Vomiting Caused By Chemotherapy
Phase II Randomized, Double-Blinded Study of an Antiemetic Pump, Using Benadryl®, Avitan® and Decadron® (BAD), for Children Receiving Moderately or Highly Emetogenic Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Closed due to poor accrual and lack of feasibility to finish study per DSMB
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nausea | — | UNRESOLVED | — |
| Unspecified Childhood Solid Tumor, Protocol Specific | Childhood Solid Neoplasm | ALIAS | 0.85 |
| Vomiting | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ativan® | Drug | — | UNRESOLVED |
| Benadryl® | Drug | — | UNRESOLVED |
| Decadron® | Drug | Dexamethasone | ALIAS |
| ondansetron hydrochloride | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Benadryl® Ativan® Decadron® (BAD) Pump
- description
- 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.
- interventionNames
- Drug: Decadron®
- Drug: Benadryl®
- Drug: Ativan®
- Drug: ondansetron hydrochloride
- type
- ACTIVE_COMPARATOR
- label
- Control Arm Saline
- description
- 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.
- interventionNames
- Drug: Decadron®
- Drug: ondansetron hydrochloride
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 8 Years
- Maximum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available