Ignite Creation Date:
2024-05-05 @ 10:05 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005994
Status:
COMPLETED
Last Update Posted:
2013-03-05
First Post:
2000-07-05
Brief Title:
Patient Education in Preventing Nausea and Vomiting in Cancer Patients Receiving Chemotherapy
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
Patient Information and Antiemetic Drug Efficacy
Status:
COMPLETED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Patient education may improve the effectiveness of ondansetron in preventing nausea and vomiting in patients receiving chemotherapy
PURPOSE This randomized clinical trial is studying how well patient education works in preventing nausea and vomiting in cancer patients receiving chemotherapy
PURPOSE This randomized clinical trial is studying how well patient education works in preventing nausea and vomiting in cancer patients receiving chemotherapy
Detailed Description:
OBJECTIVES I Determine whether an educational intervention to enhance the effectiveness of ondansetron can prevent acute postchemotherapy nausea and emesis in cancer patients II Assess any potential effectiveness of the intervention on delayed postchemotherapy nausea and emesis in these patients III Examine the effect of the intervention on patient expectations
OUTLINE This is a randomized double blind multicenter study Patients are stratified by center and chemotherapy agent cisplatin vs carboplatin vs doxorubicin Patients are randomized to one of two treatment arms Arm I Patients receive standard educational materials Arm II Patients receive specific intervention material in addition to standard educational materials Patients then complete a patient information questionnaire Patients receive ondansetron orally or IV over 10-15 minutes in addition to the first 2 courses of chemotherapy Patients complete a nausea and emesis questionnaire after each of their first 2 chemotherapy treatments
PROJECTED ACCRUAL A total of 300 patients 150 per treatment arm will be accrued for this study
OUTLINE This is a randomized double blind multicenter study Patients are stratified by center and chemotherapy agent cisplatin vs carboplatin vs doxorubicin Patients are randomized to one of two treatment arms Arm I Patients receive standard educational materials Arm II Patients receive specific intervention material in addition to standard educational materials Patients then complete a patient information questionnaire Patients receive ondansetron orally or IV over 10-15 minutes in addition to the first 2 courses of chemotherapy Patients complete a nausea and emesis questionnaire after each of their first 2 chemotherapy treatments
PROJECTED ACCRUAL A total of 300 patients 150 per treatment arm will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-P00-0160 | None | None | None |
| URCC-3996 | None | None | None |