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| ID | Type | Description | Link |
|---|---|---|---|
| 001001006001 | Other Grant/Funding Number | AETSA |
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The purpose of this study is to evaluate the effectiveness of using to low intensity laser as an intervention against preventive and therapeutic oral mucositis induced by radiotherapy and chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low energy laser | Experimental | Administration of a low energy laser for oral mucositis. |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low intensity laser for oral mucositis | Device |
| ||
| Low intensity laser for oral mucositis switch off |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the effectiveness of using low-intensity laser compared with placebo as preventive and therapeutic intervention of oral mucositis induced by radiation therapy and chemotherapy. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the effectiveness of using low level laser compared with placebo in the prevention of onset of oral mucositis induced by treatment of head and neck QRT. | 24 months | |
| Evaluate the effectiveness of the use of low laser intensity versus placebo in improving the healing of oral mucositis induced by treatment of head and neck QRT. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel Torres Lagares | Contact | danieltl@us.es | ||
| MarÃa del Mar Benjumea Vargas | Contact | 955 04 04 50 | gestionensayosclinicos.fps@juntadeandalucia.es |
| Name | Affiliation | Role |
|---|---|---|
| Daniel Torres Lagares | Hospitales Universitarios Virgen del RocÃo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Virgen del RocÃo | Recruiting | Seville | 41013 | Spain |
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| Device |
Low intensity laser for oral mucositis switch off |
|
| 24 months |
| Evaluate the effectiveness of using low level laser compared with placebo in reducing pain during and after cancer treatment. | 24 months |
| Evaluate the effectiveness of using low level laser compared with placebo in analgesic use during and after cancer treatment. | 24 months |
| Assess the intervention tolerance and side effects of it. | 24 months |
| ID | Term |
|---|---|
| D013280 | Stomatitis |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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