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Osteoradionecrosis and PENTOCLO Protocol: Retrospective Study (OPEN)

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ClinicalTrials.gov Identifier: NCT04097847
Recruitment Status : Completed
First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Brief Summary:
osteoradionecrosis (ORN) affects up to 30% of irradiated patients and can occur up to several decades after stopping treatment. Differents therapeutics exist but there is no consensus concerning the management of the maxillary ORN. The understanding of new pathological mechanisms opens the way to new therapeutic perspectives.

Condition or disease Intervention/treatment
Osteoradionecrosis of Jaw Drug: Pentoxifylline-Tocopherol-Clodronate

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Study Type : Observational
Actual Enrollment : 96 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Osteoradionecrosis and PENTOCLO Protocol: Retrospective Study.
Actual Study Start Date : June 2, 2017
Actual Primary Completion Date : April 1, 2018
Actual Study Completion Date : April 1, 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Pentoxifylline-Tocopherol-Clodronate
    the aim of this retrospective study is to analyze from patient records the impact of the PENTOCLO protocol on maxillofacial osteoradionecrosis at Brest Hospital University, France.
    Other Name: Pentoclo


Primary Outcome Measures :
  1. Clinical evolution of the osteoradionecrosis lesion after introducing PENTOCLO protocol [ Time Frame: 2 years ]
    Retrospective study based on recovering patient data from medical records



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
all patients treated at Brest hospital University for ENT cancer and who had cervicofacial radiotherapy, with maxillary and / or mandibular osteoradionecrosis treated with PENTOCLO alone or in combination with other therapies
Criteria

Inclusion Criteria:

  • Patient over 18 being or having been treated by pentoclo combination for an osteoradionecrosis of the jaw

Exclusion Criteria:

  • Tumoral recidivism
  • Precocious stop of pentoclo

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): NCT04097847


Locations
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France
CHRU de Brest
Brest, France, 29609
Sponsors and Collaborators
University Hospital, Brest

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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT04097847     History of Changes
Other Study ID Numbers: OPEN (29BRC17.0115)
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoradionecrosis
Radiation Injuries
Wounds and Injuries
Clodronic Acid
Tocopherols
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
Bone Density Conservation Agents