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) studied | uterine cancer, ovarian cancer |
| Date of first enrollment | 2011/05/01 |
| Target sample size | 140 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| 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 Outcome | The 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 minimum | 20years-old |
|---|---|
| Age maximum | 70years-old |
| Gender | Female |
| Include criteria | |
| Exclude criteria | 1) 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
| Primary Sponsor | Nagasaki University (graduate school) department of Obstetrics and Gynecology |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Nagasaki University (graduate school) department of Obstetrics and Gynecology |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Shuhei Abe |
| Address | 1-7-1 sakamoto, Nagasaki, Japan Japan |
| Telephone | 095-819-7363 |
| 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 | |
| Affiliation | Nagasaki University (graduate school) Department of Obstetrics and Gynecology |