- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01822405
Treatment of Radiation-induced Fibrosis in the Upper Aerodigestive Tract Cancer by a Combination of Pentoxifylline-tocopherol and Hyperbaric Oxygen (ORT-OXI-2009)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Claudio Otón, MD
- Email: coton@ull.es
Study Locations
-
-
S/C de Tenerife
-
La Laguna, S/C de Tenerife, Spain, 38320
- Recruiting
- Hospital Universitario de Canarias
-
Contact:
- Claudio Otón, MD
- Email: coton@ull.es
-
Principal Investigator:
- Claudio Otón, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
- Follow-up for at least a year after the radiation treatment is completed.
- Absence of tumor at the time of recruitment.
- Patients with the capacity to give informed consent
Exclusion Criteria:
- Allergy or hypersensitivity to Pentoxifylline or others xanthines, or to Tocopherol (vitamin E).
- Patients taking oral anticoagulants (acenocoumarol, warfarin).
- Known hemorrhagic/coagulation disorder.
- Vitamin K deficiency due to any cause.
- Use of estrogens oral contraceptives.
- Serious bleeding or extensive retinal hemorrhage.
- Ischaemic heart diseases, including recent Myocardial Infarction.
- Serious cardiac arrhythmia.
- Severe liver disease.
- Severe renal failure (creatinine clearance <30 mL/min).
- Hypotension.
- Patients with metal objects or electronic devices such as cardiac pacemakers, artificial heart valves or cochlear implants, or any other contraindication for MRI
- Contraindication for Hyperbaric oxygen therapy.
- Patients with mobility problems.
- Female patients who are pregnant or lactating
- Any other situation or condition that, in the opinion of the investigator, may interfere with optimal participation in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Pentoxifylline + Tocopherol
Pentoxifylline 800 mg/day (400 mg/12hours) + Tocopherol 1000 mg/day oral during 6 months
|
Pentoxifylline 800 mg/day (400 mg/12hours) + Vitamin E (alfa-tocopherol) 1000 mg/day,oral during 6 months
|
Experimental: 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in skin fibrosis measured by MRI
Time Frame: From baseline to 6 month of starting treatment
|
The change is calculated as the latest time point (6 months) minus the earliest time point (baseline)
|
From baseline to 6 month of starting treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical assessment of the radiation late (delayed) toxicity for mucosal membranes, salivary glands, larynx and skin by the LENT-SOMA scale (Late Effect Normal Tissue Task Force / Subjective, Objective, Management, Analytic scale)
Time Frame: Baseline and 6 months
|
The change is calculated as the latest time point (6 months) minus the earliest time point (baseline)
|
Baseline and 6 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Claudio Otón, MD, Hospital Universitario de Canarias
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Fibrosis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Enzyme Inhibitors
- Platelet Aggregation Inhibitors
- Protective Agents
- Micronutrients
- Vitamins
- Antioxidants
- Phosphodiesterase Inhibitors
- Free Radical Scavengers
- Radiation-Protective Agents
- Vitamin E
- Tocopherols
- alpha-Tocopherol
- Tocotrienols
- Pentoxifylline
Other Study ID Numbers
- ORT-OXI-2009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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