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Completed

NCT Number: NCT02368457

Management of Mandibular ORN: PENTO as Medical Treatment

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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Key information

Conditions

Osteoradionecrosis Bone Diseases Musculoskeletal Diseases Necrosis Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Radiation Injuries Wounds and Injuries

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Vall d'Hebrón Hospital

Barcelona, 08035, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pentoxifylline and Tocopherol

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).

Other names: PENTO

Primary outcomes

  1. Bone and/or Tissue Healing as Measured With the Classification of ORN Stages, Area of Bone Exposed (mm2) and Radiological Findings (OPG).

    Time frame: From baseline to 1, 3, 6, and 9 months of starting treatment

    Clinical healing assessment as measured with the classification of ORN stages, area of bone exposed (mm2) and radiological findings (OPG).

    Intraoral bone exposure is measured in mm2.

Secondary outcomes

  1. Clinical Symptoms Evaluation, Measured Using the LENT-SOMA Scale

    Time frame: From baseline to 1,3, 6, 9 months of starting treatment

    Evaluation of symptoms improvement using the LENT-SOMA scale (Late Effect Normal Tissue Task Force / Subjective, Objective, Management, Analytic scale).

    To examine the LENT/SOMA scale prospectively using interviews and questionnaires

    Assessments were made from baseline to 1, 3, 6 and 9 months of starting treatments. The acceptability and feasibility of using the scales was examined using compliance in completion of the questionnaires.

    Maximum score: 36 Minimum score: 0

    Questionnaires have been completed for 24 patients after treatment. Higher values represents worse outcome.

    Scale categories:

    Subjective: pain, nutritional problems, difficulty in mouth openning. Objective: bone exposure, trismus, Management: analgesic treatment, oral treatment, nutrition. Analytic: radiological findings.

Sponsors and collaborators

Lead sponsor

Hospital Vall d'Hebron

Other

Registry information

Official study title

Advances in the Management of Mandibular Osteoradionecrosis: Pentoxifylline and Tocopherol as Medical Treatment

Acronym: PENTO

Important dates

Study start
2016
Primary completion
2016
Study completion
2018
First posted
Feb 23, 2015
Registry last updated
Mar 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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