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

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

Tracking Information

• First Submitted Date: March 21, 2013
• First Posted Date: April 2, 2013
• Last Update Posted Date: April 2, 2013
• Study Start Date: July 2010
• Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Treatment of Radiation-induced Fibrosis in the Upper Aerodigestive Tract Cancer by a Combination of Pentoxifylline-tocopherol and Hyperbaric Oxygen
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Fibrosis

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: March 27, 2013): 42
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 2013
• Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT01822405
• Other Study ID Numbers: ORT-OXI-2009
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Hospital Universitario de Canarias
• Study Sponsor: Hospital Universitario de Canarias
• Collaborators: Instituto Médico Tinerfeño IMETISA

Investigators

• Principal Investigator: Claudio Otón, MD; Hospital Universitario de Canarias

• PRS Account: Hospital Universitario de Canarias
• Verification Date: March 2013