Status:
UNKNOWN
Treatment of Radiation-induced Fibrosis in the Upper Aerodigestive Tract Cancer by a Combination of Pentoxifylline-tocopherol and Hyperbaric Oxygen
Lead Sponsor:
Hospital Universitario de Canarias
Collaborating Sponsors:
Instituto Médico Tinerfeño IMETISA
Conditions:
Fibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 conditi...
Detailed Description
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 pentoxifyllin...
Eligibility Criteria
Inclusion
- Over 18 years and under 70 years old.
- Patients who have received radiotherapy after being diagnosed with cancer of upper aerodigestive tract, and have skin toxicity grade II or higher.
- Follow-up for at least a year after the radiation treatment is completed.
- Absence of tumor at the time of recruitment.
- Patients with the capacity to give informed consent
Exclusion
- Allergy or hypersensitivity to Pentoxifylline or others xanthines, or to Tocopherol (vitamin E).
- Patients taking oral anticoagulants (acenocoumarol, warfarin).
- Known hemorrhagic/coagulation disorder.
- Vitamin K deficiency due to any cause.
- Use of estrogens oral contraceptives.
- Serious bleeding or extensive retinal hemorrhage.
- Ischaemic heart diseases, including recent Myocardial Infarction.
- Serious cardiac arrhythmia.
- Severe liver disease.
- Severe renal failure (creatinine clearance \<30 mL/min).
- Hypotension.
- Patients with metal objects or electronic devices such as cardiac pacemakers, artificial heart valves or cochlear implants, or any other contraindication for MRI
- Contraindication for Hyperbaric oxygen therapy.
- Patients with mobility problems.
- Female patients who are pregnant or lactating
- Any other situation or condition that, in the opinion of the investigator, may interfere with optimal participation in the study.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2013
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01822405
Start Date
July 1 2010
End Date
July 1 2013
Last Update
April 2 2013
Active Locations (1)
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1
Hospital Universitario de Canarias
San Cristóbal de La Laguna, S/C de Tenerife, Spain, 38320