Colorectal Cancer, Nausea, Vomiting
Conditions
Keywords
nausea and vomiting, colon cancer, rectal cancer
Brief 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.
Detailed description
OBJECTIVES: * To assess the prevalence of delayed nausea and vomiting in patients with colorectal cancer receiving standard anti-emetic medications during the first course of an oxaliplatin-based chemotherapy regimen (mFOLFOX6 or FOLFOX7). OUTLINE: This is a multicenter study. Patients undergo collection of demographic, diagnostic, and treatment data at baseline. Patients complete the Functional Living Index-Emesis (FLIE) questionnaire at baseline prior to first chemotherapy infusion and at 5-7 days. Patients also fill out daily patient diaries about symptoms of nausea and vomiting, and use of medications to prevent these symptoms over days 1-5.
Interventions
None listed
Sponsors
Beth Israel Medical Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentages of Participants by Gender Who Reported Nausea During the First Week of Chemotherapy | Week 1 of FOLFOX chemotherapy | — |
| 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 | Week 1 | Scale describing impact of nausea and vomiting on quality of life on a seven-point Likert Scale with higher score indicating worse quality of life. |
| Number of Participants by History of Nausea Who Reported Nausea During the First Week of Chemotherapy | week 1 | Number of participants with factors associated with increased frequency of nausea in the first cycle of chemotherapy, including history of motion sickness, history of pregnancy-related morning sickness, history of prior chemotherapy, and history of nausea associated with prior chemotherapy |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 64 |
| Total | 64 |
Baseline characteristics
| Characteristic | Patients With Colorectal Cancer Starting Chemotherapy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 26 Participants |
| Age, Categorical Between 18 and 65 years | 38 Participants |
| Region of Enrollment United States | 64 participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 64 |
| serious Total, serious adverse events | 0 / 64 |
Outcome results
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
Scale describing impact of nausea and vomiting on quality of life on a seven-point Likert Scale with higher score indicating worse quality of life.
Time frame: Week 1
Population: this data was not collected
Primary
Number of Participants by History of Nausea Who Reported Nausea During the First Week of Chemotherapy
Number of participants with factors associated with increased frequency of nausea in the first cycle of chemotherapy, including history of motion sickness, history of pregnancy-related morning sickness, history of prior chemotherapy, and history of nausea associated with prior chemotherapy
Time frame: week 1
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Females | Number of Participants by History of Nausea Who Reported Nausea During the First Week of Chemotherapy | nausea | 14 participants |
| Females | Number of Participants by History of Nausea Who Reported Nausea During the First Week of Chemotherapy | No nausea | 9 participants |
| Males | Number of Participants by History of Nausea Who Reported Nausea During the First Week of Chemotherapy | nausea | 17 participants |
| Males | Number of Participants by History of Nausea Who Reported Nausea During the First Week of Chemotherapy | No nausea | 24 participants |
Primary
Percentages of Participants by Gender Who Reported Nausea During the First Week of Chemotherapy
Time frame: Week 1 of FOLFOX chemotherapy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Females | Percentages of Participants by Gender Who Reported Nausea During the First Week of Chemotherapy | 64 percentage of participants |
| Males | Percentages of Participants by Gender Who Reported Nausea During the First Week of Chemotherapy | 34 percentage of participants |
| Transgender | Percentages of Participants by Gender Who Reported Nausea During the First Week of Chemotherapy | 100 percentage of participants |
p-value: 0.05ANOVA
Post Hoc
Number of Participants by Antiemetic Regimen Who Reported Nausea During First Cycle of Chemotherapy
Number of participants on 2-drug (5HT3 inhibitor plus steroid) versus 3 drug (2-drug regimen plus an NK-1 inhibitor) who reported nausea during the first cycle of chemotherapy. 5HT-3 inhibitors included ondansetron, dolasetron, granisetron, and palonosetron. The NK-1 inhibitor was aprepitant. The steroid was dexamethasone.
Time frame: Week 1
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Females | Number of Participants by Antiemetic Regimen Who Reported Nausea During First Cycle of Chemotherapy | No nausea | 26 participants |
| Females | Number of Participants by Antiemetic Regimen Who Reported Nausea During First Cycle of Chemotherapy | Reported nausea | 24 participants |
| Males | Number of Participants by Antiemetic Regimen Who Reported Nausea During First Cycle of Chemotherapy | Reported nausea | 6 participants |
| Males | Number of Participants by Antiemetic Regimen Who Reported Nausea During First Cycle of Chemotherapy | No nausea | 8 participants |