Suspended

ORT-OXI-2009Combination Therapy of Pentoxifylline-Tocopherol and Hyperbaric Oxygen for Radiation-induced Fibrosis in Upper Aerodigestive Tract Cancer

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Study Aim

This study aims to evaluate the effectiveness of a combination therapy using Pentoxifylline-Tocopherol and Hyperbaric Oxygen in reducing skin fibrosis caused by radiation, as measured by MRI, in individuals with upper aerodigestive tract cancer.

What is being tested

Pentoxifylline and Vitamin E Treatment

+ Pentoxifylline, Tocopherol and Oxygen Therapy

DrugOther
Who is being recruted

Pathologic Processes

+ Pathological Conditions, Signs and Symptoms

+ Fibrosis

Over 18 Years
+21 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: July 2010
See protocol details

Summary

Principal SponsorHospital Universitario de Canarias
Study ContactClaudio Otón, MDMore contacts
Last updated: April 2, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2010

Actual date on which the first participant was enrolled.

Patients with head and neck tumors often present superficial radiation induced fibrosis and other late complications of radiotherapy that can seriously affect their quality of life. 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. Both treatments in combination could produce a synergistic effect because the angiogenesis induced by hyperbaric oxygen therapy allow better access to drugs to the injury. The magnetic resonance, provides data of the fibrosis and other side effects of radiotherapy.

NCT01822405
Principal SponsorHospital Universitario de Canarias
Study ContactClaudio Otón, MDMore contacts
Last updated: April 2, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

42 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Pathologic ProcessesPathological Conditions, Signs and SymptomsFibrosis

Criteria

5 inclusion criteria required to participate
Absence of tumor at the time of recruitment
Follow-up for at least a year after the radiation treatment is completed
Over 18 years and under 70 years old
Patients who have received radiotherapy after being diagnosed with cancer of upper aerodigestive tract, and have skin toxicity grade II or higher
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16 exclusion criteria prevent from participating
Allergy or hypersensitivity to Pentoxifylline or others xanthines, or to Tocopherol (vitamin E)
Any other situation or condition that, in the opinion of the investigator, may interfere with optimal participation in the study
Contraindication for Hyperbaric oxygen therapy
Female patients who are pregnant or lactating
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Pentoxifylline 800 mg/day (400 mg/12hours) + Tocopherol 1000 mg/day oral during 6 months

Group II

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Hospital Universitario de Canarias

San Cristóbal de La Laguna, SpainOpen Hospital Universitario de Canarias in Google Maps
SuspendedOne Study Center