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Management of Mandibular ORN: PENTO as Medical Treatment (PENTO)

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ClinicalTrials.gov Identifier: NCT02368457
Recruitment Status : Completed
First Posted : February 23, 2015
Results First Posted : December 20, 2016
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Miriam Martos-Fernandez, Hospital Vall d'Hebron

Brief 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.


Condition or disease Intervention/treatment Phase
Osteoradionecrosis Drug: Pentoxifylline and Tocopherol Phase 4

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Advances in the Management of Mandibular Osteoradionecrosis: Pentoxifylline and Tocopherol as Medical Treatment
Study Start Date : February 2016
Actual Primary Completion Date : February 2016
Actual Study Completion Date : January 1, 2018


Arm Intervention/treatment
Experimental: Pentoxifylline and Tocopherol
Drug: pentoxifylline with tocopherol Combination of pentoxifylline and tocopherol during a minimum of 6 months and a maximum of 24 months.
Drug: 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).
Other Name: PENTO

No Intervention: CONTROL
No drug treatment



Primary Outcome Measures :
  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 Outcome Measures :
  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.




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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02368457


Locations
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Spain
Vall d'Hebrón Hospital
Barcelona, Spain, 08035
Sponsors and Collaborators
Hospital Vall d'Hebron
Investigators
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Principal Investigator: Miriam Martos-Fernandez, MD Oral and Maxillofacial Surgery (Vall d'Hebrón Hospital)

Publications:
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Responsible Party: Miriam Martos-Fernandez, Oral and Maxillofacial Surgeon, Hospital Vall d'Hebron
ClinicalTrials.gov Identifier: NCT02368457     History of Changes
Other Study ID Numbers: ORN-2014-16
First Posted: February 23, 2015    Key Record Dates
Results First Posted: December 20, 2016
Last Update Posted: March 22, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Miriam Martos-Fernandez, Hospital Vall d'Hebron:
Tocopherol
vitamine E
Mandibular osteoradionecrosis
pentoxifylline
wounds and injuries
antioxidants
free radical scavengers
radiation-protective agents
vasodilatadors agents
osteonecrosis
mandible
extraoral fistula
exposed bone
necrotic bone
head and neck radiotherapy

Additional relevant MeSH terms:
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Tocopherols
Vitamin E
Tocotrienols
alpha-Tocopherol
Osteoradionecrosis
Radiation Injuries
Wounds and Injuries
Pentoxifylline
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Vasodilator Agents
Free Radical Scavengers
Antioxidants
Vitamins
Micronutrients
Nutrients
Growth Substances