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Trial record 39 of 448 for:    diphenhydramine

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

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ClinicalTrials.gov Identifier: NCT00429702
Recruitment Status : Terminated (Closed due to poor accrual and lack of feasibility to finish study per DSMB)
First Posted : February 1, 2007
Results First Posted : July 25, 2014
Last Update Posted : July 25, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of South Florida

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Supportive Care
Conditions Nausea
Vomiting
Unspecified Childhood Solid Tumor, Protocol Specific
Interventions Drug: Decadron®
Drug: Benadryl®
Drug: Ativan®
Drug: ondansetron hydrochloride
Enrollment 7
Recruitment Details Recruitment took place at participating SunCoast CCOP Research Base affiliated CCOPs and MB-CCOP institutions. Potential subjects may be provided with a paper study brochure that included a brief study overview by study staff. No recruitment or dissemination of any study brochures or materials occured prior to each site obtaining IRB approval.
Pre-assignment Details  
Arm/Group Title Benadryl® Ativan® Decadron® (BAD) Pump Control Arm Saline
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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.

Decadron®: Given IV

Benadryl®: Given IV

Ativan®: Given IV

ondansetron hydrochloride: Given IV

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.

Decadron®: Given IV

ondansetron hydrochloride: Given IV

Period Title: Overall Study
Started 3 4
Completed 3 4
Not Completed 0 0
Arm/Group Title Benadryl® Ativan® Decadron® (BAD) Pump Control Arm Saline Total
Hide Arm/Group 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.

Decadron®: Given IV

Benadryl®: Given IV

Ativan®: Given IV

ondansetron hydrochloride: Given IV

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.

Decadron®: Given IV

ondansetron hydrochloride: Given IV

Total of all reporting groups
Overall Number of Baseline Participants 3 4 7
Hide Baseline Analysis Population Description
Baseline number of participants was determined by the number of participants that completed their Baseline Study visit.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 4 participants 7 participants
<=18 years
2
  66.7%
4
 100.0%
6
  85.7%
Between 18 and 65 years
1
  33.3%
0
   0.0%
1
  14.3%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 4 participants 7 participants
Female
1
  33.3%
1
  25.0%
2
  28.6%
Male
2
  66.7%
3
  75.0%
5
  71.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 4 participants 7 participants
3 4 7
1.Primary Outcome
Title Proportion of Patients Requiring Rescue Medication for Breakthrough Nausea or Emesis During Inpatient Chemotherapy
Hide Description 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.
Time Frame during in-patient cycle of chemotherapy, up to 4 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Benadryl® Ativan® Decadron® (BAD) Pump Control Arm Saline
Hide Arm/Group 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.

Decadron®: Given IV

Benadryl®: Given IV

Ativan®: Given IV

ondansetron hydrochloride: Given IV

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.

Decadron®: Given IV

ondansetron hydrochloride: Given IV

Overall Number of Participants Analyzed 3 4
Measure Type: Number
Unit of Measure: participants
1 3
2.Secondary Outcome
Title Proportion of Patients Requiring Rescue Medication for Breakthrough Nausea or Emesis After Completion of the First Course of Emetogenic Chemotherapy
Hide Description 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.
Time Frame 3 days of following completion of first chemotherapy cycle
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Benadryl® Ativan® Decadron® (BAD) Pump Control Arm Saline
Hide Arm/Group 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.

Decadron®: Given IV

Benadryl®: Given IV

Ativan®: Given IV

ondansetron hydrochloride: Given IV

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.

Decadron®: Given IV

ondansetron hydrochloride: Given IV

Overall Number of Participants Analyzed 3 4
Measure Type: Number
Unit of Measure: participants
3 4
Time Frame Adverse events (AEs) were assessed daily beginning with the first cycle of chemotherapy and administration of study agent/placebo until 3 days following completion of chemotherapy cycle.
Adverse Event Reporting Description AEs were assessed by study staff during in-patient chemotherapy, at discharge and 3 days following completion of chemotherapy with patient and patient's primary caregiver. AEs were also assessed using the Adapted Rhodes Index of Nausea, Vomiting and Retching Measured by Children and Parents that were completed twice daily.
 
Arm/Group Title Benadryl® Ativan® Decadron® (BAD) Pump Control Arm Saline
Hide Arm/Group 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.

Decadron®: Given IV

Benadryl®: Given IV

Ativan®: Given IV

ondansetron hydrochloride: Given IV

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.

Decadron®: Given IV

ondansetron hydrochloride: Given IV

All-Cause Mortality
Benadryl® Ativan® Decadron® (BAD) Pump Control Arm Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Benadryl® Ativan® Decadron® (BAD) Pump Control Arm Saline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      0/4 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Benadryl® Ativan® Decadron® (BAD) Pump Control Arm Saline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      1/4 (25.00%)    
Surgical and medical procedures     
Pain associated with biopsy  1 [1]  0/3 (0.00%)  0 1/4 (25.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Pain associated with biopsy required during in-patient chemotherapy. Biopsy not related to study treatment or procedures and was scheduled prior to subject going on study.
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: SunCoast CCOP Research Base Lead Biostatistician
Organization: SunCoast CCOP Research Base
Phone: 18009091242
Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT00429702     History of Changes
Other Study ID Numbers: SCUSF 0503
SCUSF-0503 ( Other Identifier: SunCoast CCOP Research Base )
HLMCC-0503 ( Other Identifier: H. Lee Moffitt Cancer Center Research Base )
U10CA081920 ( U.S. NIH Grant/Contract )
First Submitted: January 31, 2007
First Posted: February 1, 2007
Results First Submitted: March 24, 2014
Results First Posted: July 25, 2014
Last Update Posted: July 25, 2014