Clinical trial NCT01822405: Treatment of Radiation-induced Fibrosis in the Upper Aerodigestive Tract Cancer by a Combination of Pentoxifylline-tocopherol and Hyperbaric Oxygen
Official title: Treatment of Radiation-induced Fibrosis in the Upper Aerodigestive Tract Cancer by a Combination of Pentoxifylline-tocopherol and Hyperbaric Oxygen
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Fibrosis
Lead sponsor: Hospital Universitario de Canarias
Sponsor class: OTHER
Collaborators: name: Instituto Médico Tinerfeño IMETISA
First posted: 2013-04-02
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in skin fibrosis measured by MRI
timeFrame: From baseline to 6 month of starting treatment
Secondary outcomes:
measure: Clinical assessment of the radiation late (delayed) toxicity for mucosal membranes, salivary glands, larynx and skin by the LENT-SOMA scale (Late Effect Normal Tissue Task Force / Subjective, Objective, Management, Analytic scale)
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias
state: S/C de Tenerife
Study officials:
affiliation: Hospital Universitario de Canarias
name: Claudio Otón, MD
role: PRINCIPAL_INVESTIGATOR
References: