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.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000039076

Enrollment

234

Registered

2020-01-31

Start date

2020-01-31

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian cancer

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Incidence of vomiting during the 21 days after starting olaparib or niraparib.	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactHirotoshi Iihara

Gifu University Hospital Department of Pharmacy

dai0920@gifu-u.ac.jp+81-58-230-6000

Outcome results