Unique ID issued by UMIN | UMIN000039175 |
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Receipt number | R000044680 |
Scientific Title | Trifluridine/tipiracil(TAS-102)-induced nausea and vomiting in patients with colorectal cancer: a prospective, observational, multicenter study |
Date of disclosure of the study information | 2020/01/31 |
Last modified on | 2024/01/20 10:52:11 |
Trifluridine/tipiracil(TAS-102)-induced nausea and vomiting in patients with colorectal cancer: a prospective, observational, multicenter study
Trifluridine/tipiracil(TAS-102)-induced nausea and vomiting in patients with colorectal cancer: a prospective, observational, multicenter study
Trifluridine/tipiracil(TAS-102)-induced nausea and vomiting in patients with colorectal cancer: a prospective, observational, multicenter study
Trifluridine/tipiracil(TAS-102)-induced nausea and vomiting in patients with colorectal cancer: a prospective, observational, multicenter study
Japan |
colorectal cancer
Gastroenterology | Gastrointestinal surgery |
Malignancy
NO
To investigate the incidence of nausea and vomiting caused by TAS-102 administration and the actual situation of antiemetic therapy.
Safety,Efficacy
Incidence of vomiting during the 14 days after starting TAS-102
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
Observational
20 | years-old | <= |
Not applicable |
Male and Female
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
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
234
1st name | Kenji |
Middle name | |
Last name | Okita |
Sapporo Medical University School of Medicine
Department of Surgery, Surgical Oncology and Science
060-8556
S1W17, Chuo-ku, Sapporo, Japan
+81-11-611-2111
okita@sapmed.ac.jp
1st name | Hirotoshi |
Middle name | |
Last name | Iihara |
Gifu University Hospital
Department of Pharmacy
501-1194
1-1 Yanagido, Gifu, Gifu
+81-58-230-6000
dai0920@gifu-u.ac.jp
Gifu University
None
Self funding
Gifu University
1-1 Yanagido, Gifu, Gifu
+81-58-230-6059
rinri@gifu-u.ac.jp
NO
2020 | Year | 01 | Month | 31 | Day |
Unpublished
119
No longer recruiting
2020 | Year | 01 | Month | 08 | Day |
2020 | Year | 01 | Month | 08 | Day |
2020 | Year | 01 | Month | 31 | Day |
2025 | Year | 12 | Month | 31 | Day |
Design
A prospective, observational, multicenter study
Patients
Patients with colorectal cancer who are scheduled to receive TAS-102
Survey item
1.Patient's background
2.Nausea, vomiting, rescue medications, anorexia, taste disorders, constipation, diarrhea, insomnia (from patient diary)
3.Patient satisfaction
2020 | Year | 01 | Month | 16 | Day |
2024 | Year | 01 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044680
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