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Trial record 5 of 15 for:    oxi

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

Tracking Information
First Submitted Date  ICMJE March 21, 2013
First Posted Date  ICMJE April 2, 2013
Last Update Posted Date April 2, 2013
Study Start Date  ICMJE July 2010
Estimated Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2013)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2013)
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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Radiation-induced Fibrosis in the Upper Aerodigestive Tract Cancer by a Combination of Pentoxifylline-tocopherol and Hyperbaric Oxygen
Official Title  ICMJE Treatment of Radiation-induced Fibrosis in the Upper Aerodigestive Tract Cancer by a Combination of Pentoxifylline-tocopherol and Hyperbaric Oxygen
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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Fibrosis
Intervention  ICMJE
  • 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.

Study Arms  ICMJE
  • Active Comparator: Pentoxifylline + Tocopherol
    Pentoxifylline 800 mg/day (400 mg/12hours) + Tocopherol 1000 mg/day oral during 6 months
    Intervention: Drug: pentoxifylline with tocopherol
  • Experimental: pentoxifylline + tocopherol + Hyperbaric Oxygen Therapy
    Intervention: Other: pentoxifylline+tocopherol + Hyperbaric Oxygen Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 27, 2013)
42
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2013
Estimated Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01822405
Other Study ID Numbers  ICMJE ORT-OXI-2009
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hospital Universitario de Canarias
Study Sponsor  ICMJE Hospital Universitario de Canarias
Collaborators  ICMJE Instituto Médico Tinerfeño IMETISA
Investigators  ICMJE
Principal Investigator: Claudio Otón, MD Hospital Universitario de Canarias
PRS Account Hospital Universitario de Canarias
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP