Clinical Trial: Management of Mandibular ORN: PENTO as Medical Treatment
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Advances in the Management of Mandibular Osteoradionecrosis: Pentoxifylline and Tocopherol as Medical Treatment
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.
Detailed Summary:
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.
Sponsor: Hospital Vall d'Hebron
Current Primary Outcome: 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.
Original Primary Outcome: 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, 12, 24 months of starting treatment ]
Current Secondary Outcome: 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.
Original Secondary Outcome: Clinical symptoms evaluation, measured using the LENT-SOMA scale (Late Effect Normal Tissue Task Force / Subjective, Objective, Management, Analytic scale). [ Time Frame: From baseline to 1,3, 6, 12, 24 months of starting treatment ]
Information By: Hospital Vall d'Hebron
Dates:
Date Received: February 10, 2015
Date Started: February 2016
Date Completion: April 2017
Last Updated: October 25, 2016
Last Verified: October 2016
