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Treatment of Radiation-induced Fibrosis in the Upper Aerodigestive Tract Cancer by a Combination of Pentoxifylline-tocopherol and Hyperbaric Oxygen (ORT-OXI-2009)

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ClinicalTrials.gov Identifier: NCT01822405
Recruitment Status : Unknown
Verified March 2013 by Hospital Universitario de Canarias.
Recruitment status was:  Recruiting
First Posted : April 2, 2013
Last Update Posted : April 2, 2013
Sponsor:
Collaborator:
Instituto Médico Tinerfeño IMETISA
Information provided by (Responsible Party):
Hospital Universitario de Canarias

Brief 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.


Condition or disease Intervention/treatment Phase
Fibrosis Drug: pentoxifylline with tocopherol Other: pentoxifylline+tocopherol + Hyperbaric Oxygen Therapy Phase 2

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Radiation-induced Fibrosis in the Upper Aerodigestive Tract Cancer by a Combination of Pentoxifylline-tocopherol and Hyperbaric Oxygen
Study Start Date : July 2010
Estimated Primary Completion Date : July 2013
Estimated Study Completion Date : July 2013


Arm Intervention/treatment
Active Comparator: Pentoxifylline + Tocopherol
Pentoxifylline 800 mg/day (400 mg/12hours) + Tocopherol 1000 mg/day oral during 6 months
Drug: pentoxifylline with tocopherol
Pentoxifylline 800 mg/day (400 mg/12hours) + Vitamin E (alfa-tocopherol) 1000 mg/day,oral during 6 months

Experimental: pentoxifylline + tocopherol + Hyperbaric Oxygen Therapy 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.





Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Over 18 years and under 70 years old.
  2. Patients who have received radiotherapy after being diagnosed with cancer of upper aerodigestive tract, and have skin toxicity grade II or higher.
  3. Follow-up for at least a year after the radiation treatment is completed.
  4. Absence of tumor at the time of recruitment.
  5. Patients with the capacity to give informed consent

Exclusion Criteria:

  1. Allergy or hypersensitivity to Pentoxifylline or others xanthines, or to Tocopherol (vitamin E).
  2. Patients taking oral anticoagulants (acenocoumarol, warfarin).
  3. Known hemorrhagic/coagulation disorder.
  4. Vitamin K deficiency due to any cause.
  5. Use of estrogens oral contraceptives.
  6. Serious bleeding or extensive retinal hemorrhage.
  7. Ischaemic heart diseases, including recent Myocardial Infarction.
  8. Serious cardiac arrhythmia.
  9. Severe liver disease.
  10. Severe renal failure (creatinine clearance <30 mL/min).
  11. Hypotension.
  12. Patients with metal objects or electronic devices such as cardiac pacemakers, artificial heart valves or cochlear implants, or any other contraindication for MRI
  13. Contraindication for Hyperbaric oxygen therapy.
  14. Patients with mobility problems.
  15. Female patients who are pregnant or lactating
  16. Any other situation or condition that, in the opinion of the investigator, may interfere with optimal participation in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01822405


Contacts
Contact: Claudio Otón, MD coton@ull.es

Locations
Spain
Hospital Universitario de Canarias Recruiting
La Laguna, S/C de Tenerife, Spain, 38320
Contact: Claudio Otón, MD       coton@ull.es   
Principal Investigator: Claudio Otón, MD         
Sponsors and Collaborators
Hospital Universitario de Canarias
Instituto Médico Tinerfeño IMETISA
Investigators
Principal Investigator: Claudio Otón, MD Hospital Universitario de Canarias

Responsible Party: Hospital Universitario de Canarias
ClinicalTrials.gov Identifier: NCT01822405     History of Changes
Other Study ID Numbers: ORT-OXI-2009
First Posted: April 2, 2013    Key Record Dates
Last Update Posted: April 2, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
Fibrosis
Pathologic Processes
Pentoxifylline
Tocopherols
Vitamin E
Tocotrienols
alpha-Tocopherol
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Vasodilator Agents
Free Radical Scavengers
Antioxidants
Vitamins
Micronutrients
Growth Substances