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

NCT ID: NCT01822405

Last Updated: 2013-04-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2013-07-31

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 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.

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 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.

Conditions

Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pentoxifylline + Tocopherol

Pentoxifylline 800 mg/day (400 mg/12hours) + Tocopherol 1000 mg/day oral during 6 months

Group Type: ACTIVE_COMPARATOR

pentoxifylline with tocopherol

Intervention Type: DRUG

Pentoxifylline 800 mg/day (400 mg/12hours) + Vitamin E (alfa-tocopherol) 1000 mg/day,oral during 6 months

pentoxifylline + tocopherol + Hyperbaric Oxygen Therapy

Group Type: EXPERIMENTAL

pentoxifylline+tocopherol + Hyperbaric Oxygen Therapy

Intervention Type: 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.

Interventions

pentoxifylline with tocopherol

Pentoxifylline 800 mg/day (400 mg/12hours) + Vitamin E (alfa-tocopherol) 1000 mg/day,oral during 6 months

Intervention Type: DRUG

pentoxifylline+tocopherol + Hyperbaric Oxygen Therapy

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.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto Médico Tinerfeño IMETISA

UNKNOWN

Sponsor Role: collaborator

Hospital Universitario de Canarias

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claudio Otón, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario de Canarias

Locations

Hospital Universitario de Canarias

San Cristóbal de La Laguna, S/C de Tenerife, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Claudio Otón, MD

Role: CONTACT

coton@ull.es

Facility Contacts

Claudio Otón, MD

Role: primary

coton@ull.es

Other Identifiers

ORT-OXI-2009

Identifier Type: -

Identifier Source: org_study_id