Treatment of Radiation-induced Fibrosis in the Upper Aerodigestive Tract Cancer by a Combination of Pentoxifylline-tocopherol and Hyperbaric Oxygen

• Status: Unknown status
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Universitario de Canarias
• Collaborator: Instituto Médico Tinerfeño IMETISA
• Treatments: alpha-Tocopherol; Pentoxifylline; Tocopherols; Tocotrienols; Vitamin E

Criteria

Inclusion Criteria:

1. Over 18 years and under 70 years old.

2. Patients who have received radiotherapy after being diagnosed with cancer of upper aerodigestive tract, and have skin toxicity grade II or higher.

3. Follow-up for at least a year after the radiation treatment is completed.

4. Absence of tumor at the time of recruitment.

5. Patients with the capacity to give informed consent

Exclusion Criteria:

1. Allergy or hypersensitivity to Pentoxifylline or others xanthines, or to Tocopherol (vitamin E).

2. Patients taking oral anticoagulants (acenocoumarol, warfarin).

3. Known hemorrhagic/coagulation disorder.

4. Vitamin K deficiency due to any cause.

5. Use of estrogens oral contraceptives.

6. Serious bleeding or extensive retinal hemorrhage.

7. Ischaemic heart diseases, including recent Myocardial Infarction.

8. Serious cardiac arrhythmia.

9. Severe liver disease.

10. Severe renal failure (creatinine clearance <30 mL/min).

11. Hypotension.

12. Patients with metal objects or electronic devices such as cardiac pacemakers, artificial heart valves or cochlear implants, or any other contraindication for MRI

13. Contraindication for Hyperbaric oxygen therapy.

14. Patients with mobility problems.

15. Female patients who are pregnant or lactating

16. Any other situation or condition that, in the opinion of the investigator, may interfere with optimal participation in the study.