Trial Outcomes & Findings for Dexamethasone and Ondansetron Hydrochloride or Palonosetron Hydrochloride in Preventing Nausea and Vomiting in Patients Receiving Doxorubicin Hydrochloride and Cyclophosphamide For Early Stage Breast Cancer (NCT NCT00343863)
NCT ID: NCT00343863
Last Updated: 2017-07-11
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
At 0-24 hours after weekly intravenous doxorubin
Results posted on
2017-07-11
Participant Flow
Participant milestones
| Measure |
Dexamethasone + Ondansetron IV
All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.
Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).
|
Dexamethasone + Palonosetron IV
All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.
Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
34
|
|
Overall Study
COMPLETED
|
7
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dexamethasone and Ondansetron Hydrochloride or Palonosetron Hydrochloride in Preventing Nausea and Vomiting in Patients Receiving Doxorubicin Hydrochloride and Cyclophosphamide For Early Stage Breast Cancer
Baseline characteristics by cohort
| Measure |
Dexamethasone + Ondansetron IV
n=7 Participants
All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.
Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).
|
Dexamethasone + Palonosetron IV
n=34 Participants
All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.
Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54 years
n=5 Participants
|
49 years
n=7 Participants
|
50 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 0-24 hours after weekly intravenous doxorubinOutcome measures
| Measure |
Dexamethasone + Ondansetron IV
n=7 Participants
All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.
Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).
|
Dexamethasone + Palonosetron IV
n=34 Participants
All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.
Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).
|
|---|---|---|
|
Count of Patients Achieving a Complete Response
|
3 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: At 24-120 hours after weekly intravenous doxorubicinOutcome measures
| Measure |
Dexamethasone + Ondansetron IV
n=7 Participants
All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.
Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).
|
Dexamethasone + Palonosetron IV
n=34 Participants
All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.
Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).
|
|---|---|---|
|
Count of Patients Achieving Complete Response
|
3 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Up to 3 monthsOutcome measures
| Measure |
Dexamethasone + Ondansetron IV
n=7 Participants
All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.
Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).
|
Dexamethasone + Palonosetron IV
n=34 Participants
All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.
Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).
|
|---|---|---|
|
Number of Days With Emetic Episodes and Rescue Medicines
Vomiting during neoadjuvant chemotherapy
|
0 days
Interval 0.0 to 51.0
|
0 days
Interval 0.0 to 51.0
|
|
Number of Days With Emetic Episodes and Rescue Medicines
Took rescue medicines
|
2 days
Interval 0.0 to 70.0
|
9.5 days
Interval 0.0 to 70.0
|
SECONDARY outcome
Timeframe: Up to 48 hours of chemotherapyCount of patients that had emesis within 48 hours of chemotherapy
Outcome measures
| Measure |
Dexamethasone + Ondansetron IV
n=7 Participants
All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.
Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).
|
Dexamethasone + Palonosetron IV
n=34 Participants
All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.
Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).
|
|---|---|---|
|
Number of Participants That Had Emesis Within 48 Hours of Chemotherapy
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: up to 48 hours of chemotherapyCount of patients that had first administration of rescue medication within 48 Hours
Outcome measures
| Measure |
Dexamethasone + Ondansetron IV
n=7 Participants
All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.
Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).
|
Dexamethasone + Palonosetron IV
n=34 Participants
All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.
Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).
|
|---|---|---|
|
Number of Participants That Had First Administration of Rescue Medication Within 48 Hours
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Days 1-7 of each cyclePopulation: Patients were unable to consistently complete this part of the FLIE questionnaire and thus we did not retain data from any of the participants.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 monthsOutcome measures
| Measure |
Dexamethasone + Ondansetron IV
n=7 Participants
All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.
Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).
|
Dexamethasone + Palonosetron IV
n=34 Participants
All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.
Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).
|
|---|---|---|
|
Side Effects of Antiemetic Medications Used
Constipation
|
2 Participants
|
15 Participants
|
|
Side Effects of Antiemetic Medications Used
Headaches
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 3 monthsCount of participants with severe nausea
Outcome measures
| Measure |
Dexamethasone + Ondansetron IV
n=7 Participants
All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.
Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).
|
Dexamethasone + Palonosetron IV
n=34 Participants
All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.
Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).
|
|---|---|---|
|
Severity of Nausea
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to 3 monthsOutcome measures
| Measure |
Dexamethasone + Ondansetron IV
n=35 FLIE questionnaires
All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.
Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).
|
Dexamethasone + Palonosetron IV
n=366 FLIE questionnaires
All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.
Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).
|
|---|---|---|
|
Quality of Life
FLIE Nausea · High impact (<36)
|
4 FLIE questionnaires
|
44 FLIE questionnaires
|
|
Quality of Life
FLIE Nausea · Medium impact (36-54)
|
5 FLIE questionnaires
|
74 FLIE questionnaires
|
|
Quality of Life
FLIE Nausea · No impact of daily life (>54)
|
26 FLIE questionnaires
|
248 FLIE questionnaires
|
|
Quality of Life
FLIE Vomiting · High impact (<36)
|
1 FLIE questionnaires
|
10 FLIE questionnaires
|
|
Quality of Life
FLIE Vomiting · Medium impact (36-54)
|
3 FLIE questionnaires
|
9 FLIE questionnaires
|
|
Quality of Life
FLIE Vomiting · No impact of daily life (>54)
|
31 FLIE questionnaires
|
347 FLIE questionnaires
|
Adverse Events
Dexamethasone + Ondansetron IV
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Dexamethasone + Palonosetron IV
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dexamethasone + Ondansetron IV
n=7 participants at risk
All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.
Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).
|
Dexamethasone + Palonosetron IV
n=34 participants at risk
All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.
Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
28.6%
2/7
|
44.1%
15/34
|
|
General disorders
Headache
|
0.00%
0/7
|
5.9%
2/34
|
Additional Information
Dr. Hannah Linden
University of Washington / Seattle Cancer Care Alliance
Phone: 206-288-6989
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place