Treatment of Radiation-induced Fibrosis in the Upper Aerodigestive Tract Cancer by a Combination of Pentoxifylline-tocopherol and Hyperbaric Oxygen
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Yes
Claudio Otón, MD
Principal Investigator
Hospital Universitario de Canarias
United States: Food and Drug Administration
ORT-OXI-2009
NCT01822405
July 2010
July 2013
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