MedTrace Logo

Treatment of Radiation-induced Fibrosis in the Upper Aerodigestive Tract Cancer by a Combination of Pentoxifylline-tocopherol and Hyperbaric Oxygen

NCT01822405 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2013-04-02

No results posted yet for this study

Summary

The pentoxifylline used with tocopherol achieves a certain effectiveness in the treatment of the fibrosis.

Hyperbaric oxygen therapy has been recommended and used in a wide variety of medical conditions including the treatment of delayed radiation injuries (soft tissue and bony radiation necrosis). The hyperbaric oxygen therapy increases the formation of granulation tissue and produces angiogenesis maintained after use.

Conditions

Interventions

DRUG

pentoxifylline with tocopherol

Pentoxifylline 800 mg/day (400 mg/12hours) + Vitamin E (alfa-tocopherol) 1000 mg/day,oral during 6 months

OTHER

pentoxifylline+tocopherol + Hyperbaric Oxygen Therapy

pentoxifylline 800 mg/day (400 mg/12hours) + Vitamin E (alfa-tocopherol) 1000 mg/day, oral during 6 months. Hyperbaric Oxygen Therapy at 100% in 25 sessions of 90 minutes 5 days per week (5 weeks) at 2,4 Ata in Hyperbaric chamber, starting in 3 or 9 weeks after randomization and beginning of drug treatment.

Sponsors & Collaborators

  • Instituto Médico Tinerfeño IMETISA

    collaborator UNKNOWN

  • Hospital Universitario de Canarias

    lead OTHER

Principal Investigators

  • Claudio Otón, MD · Hospital Universitario de Canarias

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01822405 on ClinicalTrials.gov