colorectal cancer
Conditions
Interventions
None listed
Sponsors
Gifu University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients with colorectal cancer who are scheduled to receive TAS-102 2.Patients who can fulfill patient diary correctly. 3.Patients 20 years old or older 4.Written informed consent
Exclusion criteria
Exclusion criteria: 1.Patients with a reduction in the initial dose of TAS-102 2.Patients who need antiemetics at the enrollment. 3.Patients who start taking opioids within 48 hours prior to enrollment 4.Patients with ascites effusion requiring paracentesis 5.Patients with symptomatic brain metastases and cancerous meningitis 6.Patients who have gastrointestinal obstruction 7.Patients who received abdominal or pelvic irradiation within 6 days prior to enrollment 8.Patients who use any drug with antiemetic activity, including NK1RA, 5-HT3RA, corticosteroids, dopamine receptor antagonists, phenothiazine tranquilizers, SSRI, SNRI, SDA, MARTA within 6 days prior to enrollment 9.Other patients who are judged to be inappropriate for the study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of vomiting during the 14 days after starting TAS-102 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Incidence of nausea and significant nausea during the 14 days after starting TAS-102 2.Incidence of nausea, significant nausea, and vomiting during the 28 days after starting TAS-102 3.Proportion of patients who receiving prophylactic antiemetic therapy at the start of TAS-102 4.Percentage of patients who receiving antiemetic therapy during the entire study period and number of total days of antiemetic therapy 5.Complete response (no emesis, no rescue medication) rate during the 21 days after starting TAS-102 in patients receiving antiemetic therapy 6.Complete control (no emetic episodes, no rescue medication use, and no significant nausea) rate during the 21 days after starting TAS-102 in patients receiving antiemetic therapy 7.Total control rate (no emetic episodes, no rescue medication use, and no nausea) rate during the 21 days after starting TAS-102 in patients receiving antiemetic therapy 8.Incidence of nausea, significant nausea, and vomiting by type of antiemetics 9.Severity of nausea 10.Severity of anorexia 11.Severity of vomiting 12.Frequency distribution of anorexia, significant anorexia nausea, significant nausea vomiting, and amount of food intake 13.Adverse event (Pro-CTCAE and CTCAE) 14.Reason and frequency of dose reduction 15.Weight fluctuation 16.Patient satisfaction 17.Risk factor analysis for nausea, significant nausea and vomiting for patients who have not received antiemetic therapy | — |
Countries
Japan
Contacts
Public ContactHirotoshi Iihara
Gifu University Hospital Department of Pharmacy
Outcome results
None listed