Effect of pentoxifylline and vitamin E on osteoradionecrosis

Phase 1

Conditions: Osteoradionecrosis
MedDRA version: 18.0Level: PTClassification code 10031264Term: OsteonecrosisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 18.0Level: PTClassification code 10067352Term: OsteoradionecrosisSystem Organ Class: 10022117 - Injury, poisoning and procedural complications
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2015-000618-23-SE

Lead Sponsor: Västra Götalandsregionen/NÄ

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 40

Inclusion Criteria

•Tumor-free, prior radiation in head and neck region
•Tissue-scale (SH index) S0H2-3 or S1H1-3
•Men and women age =18 years
•Understand the Swedish speaking and writing

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

•Drug interactions with study medication
•Inability to swallow tablets
•Participation in a simultaneous and similar study
•Alcohol or drug abuse
•Mental illness or other conditions that the doctor/dentist deems incompatible with the study protocol

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary objective is to evaluate tissue and bone healing in the short and long term (2 years );Secondary Objective: •Pain intensity<br>•Infection<br>•Jaw opening<br>•Salivation<br>•Hearing<br>•Quality of Life <br>•Gene expression and genetic profile<br><br>;Primary end point(s): Status evaluated according Tissue-scale, with extent of bone lesion measured in mm. Primary endpoint is change in the SH index measured with clinical and radiological methods.;Timepoint(s) of evaluation of this end point: 3, 6, 9, 12, 18 and 24 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Pain intensity according to VAS scale procedures.<br>•Infection measured on a three-point scale<br>•Jaw opening measured in millimeters<br>•Salivation measured as ml stimulated saliva / min<br>•Hearing measured in tone mean (dB).<br>•Quality of Life (QLQ C-30, QLQ H & N35)<br>•Gene expression in the irradiated tissue and genetic profile<br>;Timepoint(s) of evaluation of this end point: 3, 6, 9, 12, 18 and 24 months