Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| BLNH | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare the efficacy and safety of palifermin on reducing mucositis for patients receiving autologous or allogeneic stem cell transplantation with supportive care.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Palifermin | Active Comparator | The patients belong to this arm will be given palifermin, keratinocyte growth factor, in addition to the conventional supportive care for oral mucositis. Palifermin will be given at a dose of 60 mcg/kg for 3 days before commencement of the preparative regimen and for 3 days after stem cell infusion |
|
| Normal saline | Placebo Comparator | The patients belong to this arm will be given normal saline as placebo plus conventional supportive care for oral mucositis. Normal saline will be given at the same volume and schedule with the study drug. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palifermin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of severe oral mucositis after stem cell transplantation | from onset of severe oral mucositis till resolution of the mucositis or 28 days after stem cell transplantation | 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of severe oral mucositis after stem cell transplantation | from onset of severe oral mucositis till resolution of the mucositis or 28 days after stem cell transplantation | 5 weeks |
| Average VAS score during severe oral mucositis |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D052016 | Mucositis |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D009059 | Mouth Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D051523 | Fibroblast Growth Factor 7 |
| ID | Term |
|---|---|
| D005346 | Fibroblast Growth Factors |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
from onset of severe oral mucositis till resolution of the mucositis or 28 days after stem cell transplantation
| 5 weeks |
| Requirement of opioid drugs during severe oral mucositis | from onset of severe oral mucositis till resolution of the mucositis or 28 days after stem cell transplantation | 5 weeks |
| Requirement of opioid drugs | from onset of severe oral mucositis till resolution of the mucositis or 28 days after stem cell transplantation | 5 weeks |
| Cost effectiveness of palifermin during stem cell transplantation | from admission for stem cell transplantation to discharge | 5 weeks |
| Quality of life during transplant period | 1 week before stem cell infusion to discharge | 5 weeks |
| D009057 |
| Stomatognathic Diseases |
| D011506 | Proteins |
| D001685 | Biological Factors |