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Chemotherapy-induced mucositis is an important complication after autologous stem cell transplantation. It is mainly responsible for pain and dysphagia requiring opioids and artificial nutrition. It can also induce infectious complications. A few medication has demonstrated efficacy in this setting. It has been suggested that selenium can reduce the intensity of mucositis due to its antioxydant activity. The investigators therefore perform a randomized study to confirm this preliminary data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Usual care |
|
| Selenium | Active Comparator | Usual care + selenium 300 µg/day (IV infusion) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selenium | Drug | Selenium 300 µg/day (IV infusion) |
| |
| Placebos |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of severe oral mucositis (grade 3-4) | 31 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of any grade oral mucositis | 31 months | |
| Number of days with severe oral mucositis | 31 months | |
| Incidence of infectious complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Angers | Angers | Maine et Loire | 49933 | France |
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| Drug |
NaCl 0,9% (IV infusion) |
|
| 31 months |
| Number of days with artifical nutrition | 31 months |
| Number of days with opioids | 31 months |
| Duration of hospitalization | 31 months |
| ID | Term |
|---|---|
| D013280 | Stomatitis |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D012643 | Selenium |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008903 | Minerals |
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