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| Name | Class |
|---|---|
| Instituto Médico Tinerfeño IMETISA | UNKNOWN |
The pentoxifylline used with tocopherol achieves a certain effectiveness in the treatment of the fibrosis.
Hyperbaric oxygen therapy has been recommended and used in a wide variety of medical conditions including the treatment of delayed radiation injuries (soft tissue and bony radiation necrosis). The hyperbaric oxygen therapy increases the formation of granulation tissue and produces angiogenesis maintained after use.
Patients with head and neck tumors often present superficial radiation induced fibrosis and other late complications of radiotherapy that can seriously affect their quality of life.
The pentoxifylline used with tocopherol achieves a certain effectiveness in the treatment of the fibrosis.
Hyperbaric oxygen therapy has been recommended and used in a wide variety of medical conditions including the treatment of delayed radiation injuries (soft tissue and bony radiation necrosis). The hyperbaric oxygen therapy increases the formation of granulation tissue and produces angiogenesis maintained after use.
Both treatments in combination could produce a synergistic effect because the angiogenesis induced by hyperbaric oxygen therapy allow better access to drugs to the injury. The magnetic resonance, provides data of the fibrosis and other side effects of radiotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pentoxifylline + Tocopherol | Active Comparator | Pentoxifylline 800 mg/day (400 mg/12hours) + Tocopherol 1000 mg/day oral during 6 months |
|
| pentoxifylline + tocopherol + Hyperbaric Oxygen Therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pentoxifylline with tocopherol | Drug | Pentoxifylline 800 mg/day (400 mg/12hours) + Vitamin E (alfa-tocopherol) 1000 mg/day,oral during 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in skin fibrosis measured by MRI | The change is calculated as the latest time point (6 months) minus the earliest time point (baseline) | From baseline to 6 month of starting treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical assessment of the radiation late (delayed) toxicity for mucosal membranes, salivary glands, larynx and skin by the LENT-SOMA scale (Late Effect Normal Tissue Task Force / Subjective, Objective, Management, Analytic scale) | The change is calculated as the latest time point (6 months) minus the earliest time point (baseline) | Baseline and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claudio Otón, MD | Contact | coton@ull.es |
| Name | Affiliation | Role |
|---|---|---|
| Claudio Otón, MD | Hospital Universitario de Canarias | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de Canarias | Recruiting | San Cristóbal de La Laguna | S/C de Tenerife | 38320 | Spain |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 3, 2014 | |
| Reset | Nov 7, 2014 |
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| pentoxifylline+tocopherol + Hyperbaric Oxygen Therapy | Other | pentoxifylline 800 mg/day (400 mg/12hours) + Vitamin E (alfa-tocopherol) 1000 mg/day, oral during 6 months. Hyperbaric Oxygen Therapy at 100% in 25 sessions of 90 minutes 5 days per week (5 weeks) at 2,4 Ata in Hyperbaric chamber, starting in 3 or 9 weeks after randomization and beginning of drug treatment. |
|
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 3, 2014 | Nov 7, 2014 |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010431 | Pentoxifylline |
| D024505 | Tocopherols |
| D006931 | Hyperbaric Oxygenation |
| ID | Term |
|---|---|
| D013805 | Theobromine |
| D014970 | Xanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D014810 | Vitamin E |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D010102 | Oxygen Inhalation Therapy |
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
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