NIPH Clinical Trials Search

JAPANESE
UMIN ID: UMIN000005494

Registered date:25/04/2011

Aprepitant for nausea, vomiting with the TC therapy of the gynecology cancer patient or the DC therapy, fosaprepitant, granisetron, protective efficacy of the dexamethasone combination therapy.

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studieduterine cancer, ovarian cancer
Date of first enrollment2011/05/01
Target sample size140
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Aprepitant on days 1 to 3 (or fosapreitant on day1) Granisetron on day 1 Dexamethasone on days 1 to 4 Granisetron on day 1 Dexamethasone on days 1 to 4

Outcome(s)

Primary OutcomeThe proportion of patients with No Emesis in overall phase (0-120 hours after administration of carboplatin on day 1)
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum70years-old
GenderFemale
Include criteria
Exclude criteria1) Patient has a serious hepatic insufficiency or renal failure 2) Patient has nausea or vomiting within 24 hours prior to chemotherapy 3) Patient has been treated with antiemetic agents within 48 hours prior to chemotherapy 4) Patient has any illness (e.g. central nervous system tumors, gastrointestinal obstruction, active peptic ulcer, brain metastasis) caused nausea or vomiting except for chemotherapy-induced nausea and vomiting 5) Patient is scheduled to receive radiation therapy to the abdomen 6) Patient has the collateral symptom that the dosage of the dexamethasone is impossible for four days 7) Patient has received Pimozide 8) Patient is judged inappropriate by the investigator as subject for this study

Related Information

Contact

public contact
Name Shuhei Abe
Address 1-7-1 sakamoto, Nagasaki, Japan Japan
Telephone 095-819-7363
E-mail koutabe@yahoo.co.jp
Affiliation Nagasaki University (graduate school) Department of Obstetrics and Gynecology
scientific contact
Name Hideaki Masuzaki
Address 1-7-1 sakamoto, Nagasaki, Japan Japan
Telephone
E-mail
Affiliation Nagasaki University (graduate school) Department of Obstetrics and Gynecology