UMIN ID: UMIN000001386
Registered date:24/09/2008
Phase I/II study of complementary therapy using curcumin for gemcitabine-refractory pancreatic cancer patients
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Advanced pancreatic cancer patients who get refractory to gemcitabine-based chemotherapy |
| Date of first enrollment | 2008/09/01 |
| Target sample size | 21 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Curcumin (8g/day) is orally added to gemcitabine-based chemotherapy until disease progression, unacceptable adverse events, patient withdrawal or death. |
Outcome(s)
| Primary Outcome | Phase I; Safety Phase II; Feasibility of complementary therapy using curcumin |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 80years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1. Patients with interstitial pneumonia or pulmonary fibrosis. 2. Patients with uncontrollable diabetes mellitus, liver disease, angina pectoris or a new onset of myocardial infarction within 3 months 3. Patients with severe infection. 4. Patients with history of severe drug allegy 5. Patients with other serious comorbid diseases 6. Patients with advanced cancer other than pancreatic cancer 7. Pregnant women or patients who wish pregnant 8. Patients with mental diseases 9. Patients who are judged inappropriate for the entry into the study by the investigater |
Related Information
| Primary Sponsor | Kyoto University Hospital, Outpatient Oncology Unit |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | none |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | Japan |
| Telephone | 075-751-3397 |
| Affiliation | Kyoto University Hospital Translational Research Center |
| scientific contact | |
| Name | Kanai Masashi |
| Address | 54 Shogoin-Kawahara-cho 54, Sakyo-ku, Kyoto Japan |
| Telephone | |
| Affiliation | Kyoto University Hospital Outpatient Oncology Unit |