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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)

Primary Purpose

Fibrosis

Status

Unknown status

Phase

Phase 2

Locations

Spain

Study Type

Interventional

Intervention

pentoxifylline with tocopherol

pentoxifylline+tocopherol + Hyperbaric Oxygen Therapy

About this trial

This is an interventional treatment trial for Fibrosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hospital Universitario de CanariasRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Pentoxifylline + Tocopherol

pentoxifylline + tocopherol + Hyperbaric Oxygen Therapy

Arm Description

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

Outcomes

Primary Outcome Measures

Change in skin fibrosis measured by MRI

The change is calculated as the latest time point (6 months) minus the earliest time point (baseline)

Secondary Outcome Measures

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)

The change is calculated as the latest time point (6 months) minus the earliest time point (baseline)

Full Information

NCT ID

NCT01822405

First Posted

March 21, 2013

Last Updated

March 27, 2013

Sponsor

Hospital Universitario de Canarias

Collaborators

Instituto Médico Tinerfeño IMETISA

1. Study Identification

Unique Protocol Identification Number

NCT01822405

Brief Title

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

Acronym

ORT-OXI-2009

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Unknown status

Study Start Date

July 2010 (undefined)

Primary Completion Date

July 2013 (Anticipated)

Study Completion Date

July 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospital Universitario de Canarias

Collaborators

Instituto Médico Tinerfeño IMETISA

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fibrosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pentoxifylline + Tocopherol

Arm Type

Active Comparator

Arm Description

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

Arm Title

pentoxifylline + tocopherol + Hyperbaric Oxygen Therapy

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

pentoxifylline with tocopherol

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

pentoxifylline+tocopherol + Hyperbaric Oxygen Therapy

Intervention Description

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 Measure Information:

Title

Change in skin fibrosis measured by MRI

Description

The change is calculated as the latest time point (6 months) minus the earliest time point (baseline)

Time Frame

From baseline to 6 month of starting treatment

Secondary Outcome Measure Information:

Title

Description

The change is calculated as the latest time point (6 months) minus the earliest time point (baseline)

Time Frame

Baseline and 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Claudio Otón, MD

coton@ull.es

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Claudio Otón, MD

Organizational Affiliation

Hospital Universitario de Canarias

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Universitario de Canarias

City

La Laguna

State/Province

S/C de Tenerife

ZIP/Postal Code

38320

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Claudio Otón, MD

coton@ull.es

First Name & Middle Initial & Last Name & Degree

Claudio Otón, MD

12. IPD Sharing Statement

Learn more about this trial

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

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