Trial Outcomes & Findings for Diphenhydramine, Lorazepam, and Dexamethasone in Treating Nausea and Vomiting Caused By Chemotherapy (NCT NCT00429702)
NCT ID: NCT00429702
Last Updated: 2014-07-25
Results Overview
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.
TERMINATED
PHASE2
7 participants
during in-patient cycle of chemotherapy, up to 4 days
2014-07-25
Participant Flow
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.
Participant milestones
| Measure |
Benadryl® Ativan® Decadron® (BAD) Pump
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
|
Control Arm Saline
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 Study
STARTED
|
3
|
4
|
|
Overall Study
COMPLETED
|
3
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Diphenhydramine, Lorazepam, and Dexamethasone in Treating Nausea and Vomiting Caused By Chemotherapy
Baseline characteristics by cohort
| Measure |
Benadryl® Ativan® Decadron® (BAD) Pump
n=3 Participants
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
|
Control Arm Saline
n=4 Participants
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
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=99 Participants
|
4 participants
n=107 Participants
|
7 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: during in-patient cycle of chemotherapy, up to 4 daysRescue 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.
Outcome measures
| Measure |
Benadryl® Ativan® Decadron® (BAD) Pump
n=3 Participants
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
|
Control Arm Saline
n=4 Participants
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
|
|---|---|---|
|
Proportion of Patients Requiring Rescue Medication for Breakthrough Nausea or Emesis During Inpatient Chemotherapy
|
1 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 3 days of following completion of first chemotherapy cycleCINV 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.
Outcome measures
| Measure |
Benadryl® Ativan® Decadron® (BAD) Pump
n=3 Participants
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
|
Control Arm Saline
n=4 Participants
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
|
|---|---|---|
|
Proportion of Patients Requiring Rescue Medication for Breakthrough Nausea or Emesis After Completion of the First Course of Emetogenic Chemotherapy
|
3 participants
|
4 participants
|
Adverse Events
Benadryl® Ativan® Decadron® (BAD) Pump
Control Arm Saline
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Benadryl® Ativan® Decadron® (BAD) Pump
n=3 participants at risk
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
|
Control Arm Saline
n=4 participants at risk
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
|
|---|---|---|
|
Surgical and medical procedures
Pain associated with biopsy
|
0.00%
0/3 • 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.
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.
|
25.0%
1/4 • Number of events 1 • 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.
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.
|
Additional Information
SunCoast CCOP Research Base Lead Biostatistician
SunCoast CCOP Research Base
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place