UMIN ID: UMIN000001339
Registered date:29/08/2008
Prospective randomized Phase II trial in nutritional support for autologous PBSCT Non-synbiotics vs Synbiotics
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | malignant lymphoma or multiple myeloma |
| Date of first enrollment | 2008/09/01 |
| Target sample size | 76 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Intervention: Use of GFO and lactobacillus in patients who receive autologous PBSCT Standard : No Use of GFO and lactobacillus in patients who receive autologous PBSCT |
Outcome(s)
| Primary Outcome | Probability of more than grade 3 intestinal regimen related toxicity |
|---|---|
| Secondary Outcome | (1) 1-year overall survival and event-free survival (2) Regimen related toxicity except intestinal toxicity (3) Engraftment (4) Infectious diseases (5) Duration of TPN (6) Dose and duration of intravenous morphine (7) Dose of insulin (8) Hyperglycemia and hypoglycemia (9) DAO activity |
Key inclusion & exclusion criteria
| Age minimum | 18years-old |
|---|---|
| Age maximum | 65years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | (1) History of stem cell transplantation (2) HIV carrier (3) Uncontrolled active infectious diseases (4) Pregnant or lactating (5) Uncontrolled psychological disorder(6) Allergy for the drugs used for the conditioning regimen (7) Allergy for GFO or lactobacillus (8) Patients who do not tolerate the maximal defined conditioning regimen due to organ dysfunction (e.g., reduce MCNU due to pulmonary dysfunction, reduce Carboplatin due to renal dysfunction) |
Related Information
| Primary Sponsor | National Cancer Center Hospital |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | the Ministry of Health, Labour and Welfare |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Shigeo Fuji |
| Address | 2-6-40, Karasugatsuji, Tennoji-ku, Osaka-city, Osaka, 543-8922, Japan Japan |
| Telephone | 0667737111 |
| s-fuji@pj8.so-net.ne.jp | |
| Affiliation | NTT West Japan Osaka Hospital Department of Hematology |
| scientific contact | |
| Name | Sung-Won Kim |
| Address | 5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan Japan |
| Telephone | 03-3542-2511 |
| skim@ncc.go.jp | |
| Affiliation | National Cancer Center Hospital Hematology and Stem Cell Transplantation |