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

Phase 2
18 Years
Open (Enrolling)

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Trial Information

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.

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Change in skin fibrosis measured by MRI

Outcome Description:

The change is calculated as the latest time point (6 months) minus the earliest time point (baseline)

Outcome Time Frame:

From baseline to 6 month of starting treatment

Safety Issue:


Principal Investigator

Claudio Otón, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hospital Universitario de Canarias


United States: Food and Drug Administration

Study ID:




Start Date:

July 2010

Completion Date:

July 2013

Related Keywords:

  • Fibrosis
  • Fibrosis