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Dexamethasone and Ondansetron Hydrochloride or Palonosetron Hydrochloride in Preventing Nausea and Vomiting in Patients Receiving Doxorubicin Hydrochloride and Cyclophosphamide For Early Stage Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00343863
First Posted: June 23, 2006
Last Update Posted: July 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Hannah Linden, University of Washington
Results First Submitted: April 14, 2017  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions: Male Breast Cancer
Nausea and Vomiting
Stage I Breast Cancer
Stage II Breast Cancer
Stage IIIA Breast Cancer
Interventions: Drug: palonosetron hydrochloride
Drug: cyclophosphamide
Drug: dexamethasone
Drug: doxorubicin hydrochloride
Procedure: quality-of-life assessment
Procedure: nausea and vomiting therapy
Procedure: management of therapy complications
Drug: ondansetron hydrochloride
Other: survey administration

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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).


Participant Flow:   Overall Study
    Dexamethasone + Ondansetron IV   Dexamethasone + Palonosetron IV
STARTED   7   34 
COMPLETED   7   34 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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).

Total Total of all reporting groups

Baseline Measures
   Dexamethasone + Ondansetron IV   Dexamethasone + Palonosetron IV   Total 
Overall Participants Analyzed 
[Units: Participants]
 7   34   41 
Age 
[Units: Years]
Median (Full Range)
 54 
 (45 to 63) 
 49 
 (29 to 69) 
 50 
 (29 to 69) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      7 100.0%      34 100.0%      41 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      1  14.3%      2   5.9%      3   7.3% 
Not Hispanic or Latino      6  85.7%      30  88.2%      36  87.8% 
Unknown or Not Reported      0   0.0%      2   5.9%      2   4.9% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      1  14.3%      0   0.0%      1   2.4% 
Asian      0   0.0%      1   2.9%      1   2.4% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      0   0.0%      0   0.0% 
White      6  85.7%      31  91.2%      37  90.2% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      2   5.9%      2   4.9% 


  Outcome Measures
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1.  Primary:   Count of Patients Achieving a Complete Response   [ Time Frame: At 0-24 hours after weekly intravenous doxorubin ]

2.  Secondary:   Count of Patients Achieving Complete Response   [ Time Frame: At 24-120 hours after weekly intravenous doxorubicin ]

3.  Secondary:   Number of Days With Emetic Episodes and Rescue Medicines   [ Time Frame: Up to 3 months ]

4.  Secondary:   Number of Participants That Had Emesis Within 48 Hours of Chemotherapy   [ Time Frame: Up to 48 hours of chemotherapy ]

5.  Secondary:   Number of Participants That Had First Administration of Rescue Medication Within 48 Hours   [ Time Frame: up to 48 hours of chemotherapy ]

6.  Secondary:   Number of Doses of Rescue Medications Used   [ Time Frame: Days 1-7 of each cycle ]

7.  Secondary:   Side Effects of Antiemetic Medications Used   [ Time Frame: Up to 3 months ]

8.  Secondary:   Severity of Nausea   [ Time Frame: Up to 3 months ]

9.  Secondary:   Quality of Life   [ Time Frame: Up to 3 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Hannah Linden
Organization: University of Washington / Seattle Cancer Care Alliance
phone: 206-288-6989
e-mail: hmlinden@uw.edu



Responsible Party: Hannah Linden, University of Washington
ClinicalTrials.gov Identifier: NCT00343863     History of Changes
Other Study ID Numbers: 6140
NCI-2010-00801 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: June 22, 2006
First Posted: June 23, 2006
Results First Submitted: April 14, 2017
Results First Posted: July 11, 2017
Last Update Posted: July 11, 2017