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

NCT00429702 | Terminated Phase 2 Results DMC

• 4 other identifiers: SCUSF 0503SCUSF-0503HLMCC-0503U10CA081920
• Study Type: interventional
• Target: 7
• Locations: 2 countries
• Sites: 7

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.

Conditions

Nausea; Vomiting; Unspecified Childhood Solid Tumor, Protocol Specific

Keywords

nausea; vomiting; emetic chemotherapy; unspecified childhood solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

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

  3 days of following completion of first chemotherapy cycle

Study Arms (2)

Benadryl® Ativan® Decadron® (BAD) Pump

EXPERIMENTAL

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.

Drug: Decadron®; Drug: Benadryl®; Drug: Ativan®; Drug: ondansetron hydrochloride

Control Arm Saline

ACTIVE COMPARATOR

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.

Drug: Decadron®; Drug: ondansetron hydrochloride

Interventions

Decadron® DRUG

Given IV

Also known as: dexamethasone

Benadryl® Ativan® Decadron® (BAD) Pump; Control Arm Saline

Benadryl® DRUG

Given IV

Also known as: diphenhydramine hydrochloride

Benadryl® Ativan® Decadron® (BAD) Pump

Ativan® DRUG

Given IV

Also known as: lorazepam

Benadryl® Ativan® Decadron® (BAD) Pump

ondansetron hydrochloride DRUG

Given IV

Also known as: Zofran, Ondisolv

Benadryl® Ativan® Decadron® (BAD) Pump; Control Arm Saline

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Florida: lead
• National Cancer Institute (NCI): collaborator

Study Sites (7)

Children's Hospital of Southwest Florida

Fort Myers, Florida, 33908, United States

Location

Arnold Palmer Hospital for Children

Orlando, Florida, 32806, United States

Location

St. Joseph's Children's Hospital of Tampa

Tampa, Florida, 33677-4227, United States

Location

University of Mississippi Cancer Clinic

Jackson, Mississippi, 39216-4505, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

CHRISTUS Santa Rosa Children's Hospital

San Antonio, Texas, 78207, United States

Location

San Jorge Children's Hospital

Santurce, 00912, Puerto Rico

Location

MeSH Terms

Conditions

Nausea; Vomiting

Interventions

Calcium Dobesilate; Dexamethasone; Diphenhydramine; Lorazepam; Ondansetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Ethylamines; Amines; Benzhydryl Compounds; Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Carbazoles; Indoles; Heterocyclic Compounds, 3-Ring

Limitations and Caveats

The study was closed prior to completing enrollment based on the recommendation by the SunCoast CCOP Research Base Data Safety Monitoring Board for a lack of feasibility and poor enrollment.

Results Point of Contact

• Title: SunCoast CCOP Research Base Lead Biostatistician
• Organization: SunCoast CCOP Research Base

ccop@epi.usf.edu

18009091242

Study Officials

• Haydar Frangoul, MD

  Vanderbilt-Ingram Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2007
• First Posted: February 1, 2007
• Study Start: October 1, 2007
• Primary Completion: August 1, 2009
• Study Completion: November 1, 2009
• Last Updated: July 25, 2014
• Results First Posted: July 25, 2014

Record last verified: 2014-06

Locations

US (6); PR (1)