Management of Mandibular ORN: PENTO as Medical Treatment

Catalan Institute of Health

Status and phase

Completed

Phase 4

Conditions

Osteoradionecrosis

Treatments

Drug: Pentoxifylline and Tocopherol

Study type

Interventional

Funder types

Other

Identifiers

NCT02368457

ORN-2014-16

Details and patient eligibility

About

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.

Full description

Mandibular osteoradionecrosis which occurs after the use of radiation therapy for the treatment of head and neck cancer remains being the most problematic and irreversible complication despite its low incidence with no medical treatment to limit or reduce symptoms.

Clinical trials conducted to date have shown a significant scientific evidence that the treatment with pentoxifylline + tocopherol achieves a certain effectiveness in the treatment of the tissue fibrosis that have been irradiated based on the properties of this drugs in increased tissue oxygenation and their antioxidant effect.

The aim of this study is to determine if there is a clinical improvement of mandibular osteoradionecrosis using Pentoxifylline in combination with Tocopherol as treatment because, currently, there is no effective treatment to achieve bone healing and/or a symptomatic improvement.

Enrollment

24 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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.