Management of Mandibular ORN: PENTO as Medical Treatment

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2018-01-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Osteoradionecrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pentoxifylline and Tocopherol

Drug: pentoxifylline with tocopherol Combination of pentoxifylline and tocopherol during a minimum of 6 months and a maximum of 24 months.

Group Type EXPERIMENTAL

Pentoxifylline and Tocopherol

Intervention Type DRUG

pentoxifylline with tocopherol Pentoxifylline 800 mg/day, oral (1cp 400 mg twice a day) + Vitamin E (alfa-tocopherol) 1000 UI/day, oral (1cp 400UI twice a day + 1cp200UI once a day) during 24 months (maximum).

CONTROL

No drug treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pentoxifylline and Tocopherol

pentoxifylline with tocopherol Pentoxifylline 800 mg/day, oral (1cp 400 mg twice a day) + Vitamin E (alfa-tocopherol) 1000 UI/day, oral (1cp 400UI twice a day + 1cp200UI once a day) during 24 months (maximum).

Intervention Type DRUG

Other Intervention Names

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PENTO

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No