FibrosisPhase 2ORT-OXI-2009NCT01822405
Treatment of Radiation-induced Fibrosis in the Upper Aerodigestive Tract Cancer by a Combination of Pentoxifylline-tocopherol and Hyperbaric Oxygen
A Phase 2 study testing pentoxifylline with tocopherol and pentoxifylline+tocopherol + Hyperbaric Oxygen Therapy in people with Fibrosis, run by Hospital Universitario de Canarias at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibrosis
- What is being tested?
- pentoxifylline with tocopherol and pentoxifylline+tocopherol + Hyperbaric Oxygen Therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2010to Jul 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Claudio Otón, MD contact
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario de Canarias
San Cristóbal de La Laguna, S/C de Tenerife, 38320
Claudio Otón, MD, coton@ull.es
Claudio Otón, MD
About this study
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.
Read the 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.
- Conditions
- Fibrosis
- Being tested
- pentoxifylline with tocopherol, pentoxifylline+tocopherol + Hyperbaric Oxygen Therapy
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pentoxifylline with tocopherolDrug
Pentoxifylline 800 mg/day (400 mg/12hours) + Vitamin E (alfa-tocopherol) 1000 mg/day,oral during 6 months
pentoxifylline+tocopherol + Hyperbaric Oxygen TherapyOther
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 group | Role | What they receive |
|---|---|---|
| Pentoxifylline + Tocopherol | Active comparator | Pentoxifylline 800 mg/day (400 mg/12hours) + Tocopherol 1000 mg/day oral during 6 months Receives: Drug: pentoxifylline with tocopherol |
| pentoxifylline + tocopherol + Hyperbaric Oxygen Therapy | Experimental | Not described Receives: Other: pentoxifylline+tocopherol + Hyperbaric Oxygen Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in skin fibrosis measured by MRI
The change is calculated as the latest time point (6 months) minus the earliest time point (baseline)
Measured: 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)
The change is calculated as the latest time point (6 months) minus the earliest time point (baseline)
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2013 (estimated)
- Study startJul 2010
- Primary completionJul 2013 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Canarias
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Médico Tinerfeño IMETISA
- Responsible party
- Sponsor
- Investigators
- Claudio Otón, MD, Principal investigator, Hospital Universitario de Canarias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01822405
- Sponsor's protocol ID
- ORT-OXI-2009
- Acronym
- ORT-OXI-2009
- Status last verified
- Mar 2013
- First submitted
- 21 Mar 2013
- Last updated
- 2 Apr 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Radiation-induced Fibrosis in the Upper Aerodigestive Tract Cancer by a Combination of Pentoxifylline-tocopherol and Hyperbaric Oxygen
- ClinicalTrials.gov ID
- NCT01822405
- Acronym / sponsor ID
- ORT-OXI-2009 / ORT-OXI-2009
- Conditions
- Fibrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Hospital Universitario de CanariasUniversity, hospital or other
- Collaborators
- Instituto Médico Tinerfeño IMETISA
- Study start
- Jul 2010
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 2 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pentoxifylline + Tocopherol | Active comparator | Drug: pentoxifylline with tocopherolPentoxifylline 800 mg/day (400 mg/12hours) + Tocopherol 1000 mg/day oral during 6 months |
| pentoxifylline + tocopherol + Hyperbaric Oxygen Therapy | Experimental | Other: pentoxifylline+tocopherol + Hyperbaric Oxygen Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pentoxifylline with tocopherolPentoxifylline 800 mg/day (400 mg/12hours) + Vitamin E (alfa-tocopherol) 1000 mg/day,oral during 6 months | Drug | Pentoxifylline + Tocopherol |
| pentoxifylline+tocopherol + Hyperbaric Oxygen Therapypentoxifylline 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. | Other | pentoxifylline + tocopherol + Hyperbaric Oxygen Therapy |
Primary outcome
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)
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudio Otón, MD contact
Claudio Otón, MD principal investigator
Hospital Universitario de Canarias
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pentoxifylline with tocopherol and pentoxifylline+tocopherol + Hyperbaric Oxygen Therapy in people with Fibrosis, run by Hospital Universitario de Canarias at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claudio Otón, MD (coton@ull.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in skin fibrosis measured by MRI (time frame: From baseline to 6 month of starting treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2013.