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

NCT01822405 | Unknown Phase 2

• 1 other identifier: ORT-OXI-2009
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibrosis

Outcome Measures

Primary Outcomes (1)

• Change in skin fibrosis measured by MRI

  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 Outcomes (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)

  Baseline and 6 months

Study Arms (2)

Pentoxifylline + Tocopherol

ACTIVE COMPARATOR

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

Drug: pentoxifylline with tocopherol

pentoxifylline + tocopherol + Hyperbaric Oxygen Therapy

EXPERIMENTAL

Other: pentoxifylline+tocopherol + Hyperbaric Oxygen Therapy

Interventions

pentoxifylline with tocopherol DRUG

Pentoxifylline 800 mg/day (400 mg/12hours) + Vitamin E (alfa-tocopherol) 1000 mg/day,oral during 6 months

Pentoxifylline + Tocopherol

pentoxifylline+tocopherol + Hyperbaric Oxygen Therapy OTHER

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.

pentoxifylline + tocopherol + Hyperbaric Oxygen Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitario de Canarias: lead
• Instituto Médico Tinerfeño IMETISA: collaborator

Study Sites (1)

Hospital Universitario de Canarias

San Cristóbal de La Laguna, S/C de Tenerife, 38320, Spain

RECRUITING

MeSH Terms

Conditions

Fibrosis

Interventions

Pentoxifylline; Tocopherols; Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Vitamin E; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• Claudio Otón, MD

  Hospital Universitario de Canarias

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claudio Otón, MD

CONTACT

coton@ull.es

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2013
• First Posted: April 2, 2013
• Study Start: July 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: April 2, 2013

Record last verified: 2013-03

Locations

ES (1)