Unique ID issued by UMIN | UMIN000039076 |
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Receipt number | R000044565 |
Scientific Title | PARP Inhibitors-induced nausea and vomiting in patients with gynecologic cancer: a prospective, observational, multicenter study. |
Date of disclosure of the study information | 2020/01/31 |
Last modified on | 2023/07/07 09:12:57 |
PARP Inhibitors-induced nausea and vomiting in patients with gynecologic cancer: a prospective, observational, multicenter study.
PARP Inhibitors-induced nausea and vomiting in patients with gynecologic cancer: a prospective, observational, multicenter study.
PARP Inhibitors-induced nausea and vomiting in patients with gynecologic cancer: a prospective, observational, multicenter study.
PARP Inhibitors-induced nausea and vomiting in patients with gynecologic cancer: a prospective, observational, multicenter study.
Japan |
Ovarian cancer
Obstetrics and Gynecology |
Malignancy
NO
To investigate the incidence of nausea and vomiting caused by PARP Inhibitors administration and the actual situation of antiemetic therapy.
Safety,Efficacy
Incidence of vomiting during the 21 days after starting olaparib or niraparib.
1.Incidence of nausea and significant nausea during the 21 days after starting olaparib or niraparib
2.Proportion of patients who receiving prophylactic antiemetic therapy at the start of olaparib or niraparib
3.Percentage of patients who receiving antiemetic therapy during the entire study period and number of total days of antiemetic therapy
4.Complete response (no emesis, no rescue medication) rate during the 21 days after starting olaparib in patients receiving antiemetic therapy
5.Complete control (no emetic episodes, no rescue medication use, and no significant nausea) rate during the 21 days after starting olaparib in patients receiving antiemetic therapy
6.Total control rate (no emetic episodes, no rescue medication use, and no nausea) rate during the 21 days after starting olaparib in patients receiving antiemetic therapy
7.Incidence of nausea, significant nausea, and vomiting by type of antiemetics
8.Severity of nausea
9.Severity of anorexia
10.Severity of vomiting
11.Frequency distribution of anorexia, significant anorexia nausea, significant nausea vomiting, and amount of food intake
12.Adverse event (Pro-CTCAE and CTCAE)
13.Reason and frequency of dose reduction
14.Weight fluctuation
15.Patient satisfaction
16.Risk factor analysis for nausea, significant nausea and vomiting for patients who have not received antiemetic therapy
Observational
20 | years-old | <= |
Not applicable |
Female
1.Patients with ovarian cancer who are scheduled to receive olaparib and niraparib
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 olaparib and niraparib
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 | Masakazu |
Middle name | |
Last name | Abe |
Shizuoka Cancer Center
Department of Gynecologic Oncology
411-8777
1007, Shimonagakubo, Nagaizumicho, Suntogun, Shizuoka
+81-55-989-5222
ma.abe@scchr.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
Japan Society for the Promotion of Science
Japanese Governmental office
Gifu University
1-1 Yanagido, Gifu, Gifu
+81-58-230-6059
rinri@gifu-u.ac.jp
NO
2020 | Year | 01 | Month | 31 | Day |
Unpublished
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 ovarian cancer who are scheduled to receive olaparib or niraparib
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 | 07 | Day |
2023 | Year | 07 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044565
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