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| ID | Type | Description | Link |
|---|---|---|---|
| BIMCP-NV-SURVEY | |||
| BIMCP-IRB-37-04 | |||
| MERCK-BIMCP-NV-SURVEY |
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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.
OBJECTIVES:
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | Week 1 |
| 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 | week 1 |
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DISEASE CHARACTERISTICS:
Diagnosis of colorectal cancer
Currently receiving OR scheduled to receive the first course of either of the following chemotherapy regimens:
No clinical or imaging evidence of brain metastasis
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Patients receiveing chemotherapy including oxaliplatin at the ambulatory care center
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| Name | Affiliation | Role |
|---|---|---|
| Stewart Barry Fleishman, MD | Beth Israel Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Medical Center - Philipps Ambulatory Care Center | New York | New York | 10003 | United States |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentages of Participants by Gender Who Reported Nausea During the First Week of Chemotherapy | Posted | Number | percentage of participants | Week 1 of FOLFOX chemotherapy |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Victoria Rosenwald, RN MPH | Beth Israel Cancer Center | 212 844-8285 | vrosenwa@chpnet.org |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D009325 | Nausea |
| D014839 | Vomiting |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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transgender subject starting chemotherapy for stage 3 or 4 colorectal cancer containing oxaliplatin. The chemotherapy is not part of the study but instead is initiated as standard care. |
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| 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. | this data was not collected | Posted | Week 1 |
|
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| 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 | Posted | Number | participants | week 1 |
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| 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. | Posted | Number | participants | Week 1 |
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| 0 |
| 64 |
| 0 |
| 64 |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |