N/A
N=64
Delayed Nausea and Vomiting in Patients With Colorectal Cancer Receiving Oxaliplatin
Colorectal Cancer · Nausea · Vomiting
Bottom Line
View on ClinicalTrials.gov: NCT00729677 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Mar 2011
Primary outcome: Primary: Percentages of Participants by Gender Who Reported Nausea During the First Week of Chemotherapy — 64; 34; 100 percentage of participants — p=.05
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Beth Israel Medical Center
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentages of Participants by Gender Who Reported Nausea During the First Week of Chemotherapy |
64; 34; 100 | .05 |
| 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 |
— | — |
| PRIMARY Number of Participants by History of Nausea Who Reported Nausea During the First Week of Chemotherapy |
14; 17; 9; 24 | — |
Summary
RATIONALE: Learning how often patients experience nausea and vomiting after receiving anti-vomiting medicine and chemotherapy for colorectal cancer may help doctors plan better treatment and improve patients' quality of life.
PURPOSE: This clinical trial is studying delayed nausea and vomiting in patients with colorectal cancer receiving standard anti-vomiting medicine during the first course of chemotherapy.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of colorectal cancer
- Currently receiving OR scheduled to receive the first course of either of the following chemotherapy regimens:
- mFOLFOX6
- FOLFOX7
- No clinical or imaging evidence of brain metastasis
PATIENT CHARACTERISTICS:
- Able to maintain a diary and complete a standardized quality of life questionnaire in English
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 90 days since prior aprepitant
Data sourced from ClinicalTrials.gov (NCT00729677). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.