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
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
Subjective: pain, nutritional problems, difficulty in mouth openning. Objective: bone exposure, trismus, Management: analgesic treatment, oral treatment, nutrition. Analytic: radiological findings.
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
|Vall d'Hebrón Hospital|
|Barcelona, Spain, 08035|
|Principal Investigator:||Miriam Martos-Fernandez, MD||Oral and Maxillofacial Surgery (Vall d'Hebrón Hospital)|