UMIN ID: UMIN000018441
Registered date:01/09/2015
A single-arm study on the effectiveness of nutritional supplements containing amino acids for chemotherapy-induced mucositis.
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Patients with hematological malignancy and need hematopoietic transplantation (autologous or allogeneic) |
| Date of first enrollment | 2015/09/01 |
| Target sample size | 30 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | To take nutritional supplements containing amino acids. |
Outcome(s)
| Primary Outcome | mucositis, diarrhea, and nausea was graded according to NCI-CTCAE 4.0 (at the point of discharge or two months from intervention) |
|---|---|
| Secondary Outcome | periods for opioids-use, fasting and discharge, change of body weight, laboratory data, overall survival, incidence of GVHD |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Patients who reject to participate in this trial, or who are in condition of being unable to make conscious judgment. |
Related Information
| Primary Sponsor | Kyoto Prefectural University of Medicine |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Kyoto Prefectural University of Medicine |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Yuji Shimura |
| Address | 465, Kajii-cho, Kamigyo-ku, Kyoto-city Japan |
| Telephone | 075-251-5740 |
| yshimura@koto.kpu-m.ac.jp | |
| Affiliation | Kyoto Prefectural University of Medicine Dept. of Hematology |
| scientific contact | |
| Name | Masafumi Taniwaki |
| Address | 465, Kajii-cho, Kamigyo-ku, Kyoto-city Japan |
| Telephone | 075-251-5740 |
| taniwaki@koto.kpu-m.ac.jp | |
| Affiliation | Kyoto Prefectural University of Medicine Dept. of Hematology |