|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Study Type: | Observational |
|---|---|
| Study Design: | Observational Model: Case-Only; Time Perspective: Prospective |
| Conditions: |
Colorectal Cancer Nausea Vomiting |
Participant Flow
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| No text entered. |
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| The original intent had been to analyze data on 100 chemotherapy cycles in 100 subjects. Instead, in order to accelerate accrual, we analyzed data on 1 cycle in 24 subjects and 2 cycles in 40 subjects. |
| Description | |
|---|---|
| Patients With Colorectal Cancer Starting Chemotherapy | patients starting chemotherapy for stage 3 or 4 colorectal cancer on regimens containing oxaliplatin. The chemotherapy is not part of the study but instead is initiated as standard care. |
| Patients With Colorectal Cancer Starting Chemotherapy | |
|---|---|
| STARTED | 64 |
| COMPLETED | 64 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Description | |
|---|---|
| Patients With Colorectal Cancer Starting Chemotherapy | patients starting chemotherapy for stage 3 or 4 colorectal cancer on regimens containing oxaliplatin. The chemotherapy is not part of the study but instead is initiated as standard care. |
| Patients With Colorectal Cancer Starting Chemotherapy | |
|---|---|
|
Number of Participants
[units: participants] |
64 |
|
Age
[units: participants] |
|
| <=18 years | 0 |
| Between 18 and 65 years | 38 |
| >=65 years | 26 |
|
Gender
[units: participants] |
|
| Female | 30 |
| Male | 34 |
|
Region of Enrollment
[units: participants] |
|
| United States | 64 |
Outcome Measures
| 1. Primary: | Percentages of Participants by Gender Who Reported Nausea During the First Week of Chemotherapy [ Time Frame: Week 1 of FOLFOX chemotherapy ] |
| 2. Primary: | Impact of Nausea and Vomiting on the Patient's Quality of Life as Measured by the Functional Living Index – Emesis Scale at 5-7 Days [ Time Frame: Week 1 ] |
| 3. Primary: | Number of Participants by History of Nausea Who Reported Nausea During the First Week of Chemotherapy [ Time Frame: week 1 ] |
| 4. Post-Hoc: | Number of Participants by Antiemetic Regimen Who Reported Nausea During First Cycle of Chemotherapy [ Time Frame: Week 1 ] |
More Information
| Principal Investigators are NOT employed by the organization sponsoring the study. |
| There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. |
| 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 |
|---|
| This was a convenience sample of patients seen at 2 medical centers. Subjects were restricted to those who could complete Quality of Life forms in Spanish or English. |
| Responsible Party: | Stewart Barry Fleishman, Beth Israel Medical Center - Philipps Ambulatory Care Center |
| ClinicalTrials.gov Identifier: | NCT00729677 History of Changes |
| Other Study ID Numbers: | 237-04, BIMCP-NV-SURVEY, BIMCP-IRB-37-04, MERCK-BIMCP-NV-SURVEY |
| Study First Received: | August 6, 2008 |
| Results First Received: | September 15, 2009 |
| Last Updated: | March 16, 2011 |
| Health Authority: | United States: Federal Government |