Effect of pentoxifylline and vitamin E on osteoradionecrosis

Treatment of osteoradionecrosis (ORN) with pentoxifylline and a-tocopherol (PENTO)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-000618-23-SE

Enrollment

Registered

2015-03-03

Start date

2015-05-05

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoradionecrosis MedDRA version: 18.0 Level: PT Classification code 10031264 Term: Osteonecrosis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 18.0 Level: PT Classification code 10067352 Term: Osteoradionecrosis System Organ Class: 10022117 - Injury, poisoning and procedural complications

Interventions

Trade Name: Trental Product Name: Trental (Pentoxifylline) Product Code: NDC:0039-0078-10 Pharmaceutical Form: Tablet INN or Proposed INN: PENTOXIFYLLINE CAS Number: 6493-05-6 Concentration unit: mg m

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Secondary

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

Measure

Time frame

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

—

Primary

Measure	Time frame
Main Objective: Primary objective is to evaluate tissue and bone healing in the short and long term (2 years );Secondary Objective: •Pain intensity •Infection •Jaw opening •Salivation •Hearing •Quality of Life •Gene expression and genetic profile ;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	—

Measure

Time frame

Main Objective: Primary objective is to evaluate tissue and bone healing in the short and long term (2 years );Secondary Objective: •Pain intensity •Infection •Jaw opening •Salivation •Hearing •Quality of Life •Gene expression and genetic profile ;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

—

Countries

Sweden

Contacts

Public ContactKäkkirurgiska kliniken

Västra Götalandsregionen/NÄL

josephine.skoldstam@vgregion.se+46(0)702-895959

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026