Study of second-generation 5-HT3-receptor antagonist; palonosetron for prevention of nausea and emesis in patients receiving chemotherapy including cisplatin for gastric cancer.

Study of second-generation 5-HT3-receptor antagonist; palonosetron for prevention of nausea and emesis in patients receiving chemotherapy including cisplatin for gastric cancer. - Effect of palonosetron in patient receiving chemotherapy including cisplatin for gastric cancer.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000009016

Enrollment

Registered

2012-10-01

Start date

2012-10-01

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

Advanced gastric cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)patients receiving first course of chemotherapy containing cisplatin for gastric cancer. 2) aged 20 years or more. 3) patents had undergone treatment with high emetic risk and moderate emetic risk chemotherapy prior to this study 4) written informed consent from the patients.

Exclusion criteria

Exclusion criteria: 1) patients with serious hepatic insufficiency or renal failure. 2) patients with emesis within 24 hours before first administrating of cisplatin. 3) patients who were administered antiemetic drugs within 48 hours before first administrating of cisplatin. 4) patients with emetic factor except for chemotherapy 5) patient who was intended radiation therapy 6) patients judged inappropriate for this study by physicians. 7) patients who received Pimozide.

Design outcomes

Primary

Measure	Time frame
Ratio of complete response (defined as no emesis and no rescue treatment). [Time Frame: overall; 0-120hr after chemotherapy, acute phase; 0-24hr, delayed phase; 24-120hr].	—

Secondary

Measure	Time frame
1) ratio of patient without emesis. 2) ratio of patient without rescue treatment. 3) ratio of patient without nausea. 4) time to first emesis. 5) evaluation of volume of meal intake. 6) evaluation of QOL with Functional Living index-Emesis (FLIE) scale.	—

Countries

Japan

Contacts

Public ContactKatsunobu Oyama

Digestive Disease Support Organization (DDSO) Gastroenterologic surgery

oya-ma@staff.kanazawa-u.ac.jp076-265-2000

Outcome results