UMIN ID: UMIN000054250
Registered date:01/05/2024
A study on antiemetic drugs in breast cancer chemotherapy
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | Breast Cancer |
| Date of first enrollment | 2024/05/01 |
| Target sample size | 100 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | No nausea during the overall assessment period (0 to 120 hours) on the first course |
|---|---|
| Secondary Outcome | 1. Complete response 2. Complete control 3. Total control 4. Time to treatment failure 5. Daytime somnolence 6. Change in dosage of olanzapine 7. Satisfaction with antiemetic therapy |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 75years-old |
| Gender | Female |
| Include criteria | |
| Exclude criteria | 1. Concurrent use of antiemetic agent. 2. Start of opioid analgesic for 14 days before registration. 3. Subjects on anticonvulsant therapy. 4. Gastrointestinal obstruction (e.g. gastropyloric stenosis, intestinal obstruction). 5. Diagnosis of diabetes mellitus(e.g., on insulin or an oral hypoglycemic agent). |
Related Information
| Primary Sponsor | National Hospital Organization Kyushu Cancer Center |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | None |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Ayako Higuchi |
| Address | 3-1-1 Notame Minami-ku Fukuoka city Fukuoka Japan 811-1395 |
| Telephone | 092-541-3231 |
| higuchi.ayako.jn@mail.hosp.go.jp | |
| Affiliation | National Hospital Organization Kyushu Cancer Center Department of Pharmacy |
| scientific contact | |
| Name | Hiroaki Shimizu |
| Address | 3-1-1 Notame Minami-ku Fukuoka city Fukuoka Japan |
| Telephone | 092-541-3231 |
| shimizu.hiroaki.bc@mail.hosp.go.jp | |
| Affiliation | National Hospital Organization Kyushu Cancer Center Department of Pharmacy |