Management of Mandibular ORN: PENTO as Medical Treatment

• Status: Completed
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Mandibular osteoradionecrosis, despite its low incidence, remains being the most problematic and irreversible complication after head and neck radiotherapy with no medical treatment to limit or reduce symptoms.

Different clinical trials have shown a significant scientific evidence that the treatment with pentoxifylline + tocopherol achieves a certain effectiveness in the treatment of the tissue fibrosis. This study proposes to use this drugs to determine if there is healing of mandibular osteoradionecrosis and/or a symptomatic improvement as well.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Vall d'Hebron
• Treatments: alpha-Tocopherol; Pentoxifylline; Tocopherols; Tocotrienols; Vitamin E

Criteria

Inclusion Criteria:

• Over 18 years and under 90 years old.

• Patients who have received radiotherapy after being diagnosed with head and neck cancer and currently are diagnosticated of mandibular osteoradionecrosis (any clinical stage)

• 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 Criteria:

• 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.

• 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.