A Phase 4 interventional study of Pentoxifylline and Tocopherol in Osteoradionecrosis, sponsored by Hospital Vall d'Hebron. Completed at 1 site in Spain. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2018-03-22.
Sponsored by Hospital Vall d'Hebron · Phase 4, Interventional, and Treatment
Mandibular osteoradionecrosis, despite its low incidence, remains being the most problematic and irreversible complication after head and neck radiotherapy with no medical treatment to limit or reduce symptoms.
Different clinical trials have shown a significant scientific evidence that the treatment with pentoxifylline + tocopherol achieves a certain effectiveness in the treatment of the tissue fibrosis. This study proposes to use this drugs to determine if there is healing of mandibular osteoradionecrosis and/or a symptomatic improvement as well.
Mandibular osteoradionecrosis which occurs after the use of radiation therapy for the treatment of head and neck cancer remains being the most problematic and irreversible complication despite its low incidence with no medical treatment to limit or reduce symptoms.
Clinical trials conducted to date have shown a significant scientific evidence that the treatment with pentoxifylline + tocopherol achieves a certain effectiveness in the treatment of the tissue fibrosis that have been irradiated based on the properties of this drugs in increased tissue oxygenation and their antioxidant effect.
The aim of this study is to determine if there is a clinical improvement of mandibular osteoradionecrosis using Pentoxifylline in combination with Tocopherol as treatment because, currently, there is no effective treatment to achieve bone healing and/or a symptomatic improvement.
24 studies on the registry are indexed under Osteoradionecrosis; 8 are open to participants now.
This study's enrollment of 24 is below the median of 60 across 13 interventional studies indexed under Osteoradionecrosis.
Browse Osteoradionecrosis studies →Hospital Vall d'Hebron is the lead sponsor of 18 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: pentoxifylline with tocopherol Combination of pentoxifylline and tocopherol during a minimum of 6 months and a maximum of 24 months.
Drug: Pentoxifylline and Tocopherol
No drug treatment
Drug pages: Pentoxifylline · Tocopherols
pentoxifylline with tocopherol Pentoxifylline 800 mg/day, oral (1cp 400 mg twice a day) + Vitamin E (alfa-tocopherol) 1000 UI/day, oral (1cp 400UI twice a day + 1cp200UI once a day) during 24 months (maximum).
Also known as: PENTO
Bone and/or Tissue Healing as Measured With the Classification of ORN Stages, Area of Bone Exposed (mm2) and Radiological Findings (OPG).
Clinical healing assessment as measured with the classification of ORN stages, area of bone exposed (mm2) and radiological findings (OPG). Intraoral bone exposure is measured in mm2.
Time frame: From baseline to 1, 3, 6, and 9 months of starting treatment
Clinical Symptoms Evaluation, Measured Using the LENT-SOMA Scale
Evaluation of symptoms improvement using the LENT-SOMA scale (Late Effect Normal Tissue Task Force / Subjective, Objective, Management, Analytic scale). To examine the LENT/SOMA scale prospectively using interviews and questionnaires Assessments were made from baseline to 1, 3, 6 and 9 months of starting treatments. The acceptability and feasibility of using the scales was examined using compliance in completion of the questionnaires. Maximum score: 36 Minimum score: 0 Questionnaires have been completed for 24 patients after treatment. Higher values represents worse outcome. Scale categories: Subjective: pain, nutritional problems, difficulty in mouth openning. Objective: bone exposure, trismus, Management: analgesic treatment, oral treatment, nutrition. Analytic: radiological findings.
Time frame: From baseline to 1,3, 6, 9 months of starting treatment
| Milestone | Pentoxifylline and Tocopherol | Control Group |
|---|---|---|
| Started | 12 | 12 |
| Completed | 12 | 12 |
| Not completed | 0 | 0 |
Clinical healing assessment as measured with the classification of ORN stages, area of bone exposed (mm2) and radiological findings (OPG). Intraoral bone exposure is measured in mm2.
| mm2 | Pentoxifylline and Tocopherol | Control Group |
|---|---|---|
| 1 month of starting treatment | 14 (10 to 18) | 15 (10 to 20) |
| 3 month of starting treatment | 13 (10 to 16) | 15 (10 to 20) |
| 6 month of starting treatment | 11.5 (10 to 13) | 15 (10 to 20) |
| 9 month of starting treatment | 10 (8 to 12) | 15 (10 to 20) |
Evaluation of symptoms improvement using the LENT-SOMA scale (Late Effect Normal Tissue Task Force / Subjective, Objective, Management, Analytic scale). To examine the LENT/SOMA scale prospectively using interviews and questionnaires Assessments were made from baseline to 1, 3, 6 and 9 months of starting treatments. The acceptability and feasibility of using the scales was examined using compliance in completion of the questionnaires. Maximum score: 36 Minimum score: 0 Questionnaires have been completed for 24 patients after treatment. Higher values represents worse outcome. Scale categories: Subjective: pain, nutritional problems, difficulty in mouth openning. Objective: bone exposure, trismus, Management: analgesic treatment, oral treatment, nutrition. Analytic: radiological findings.
| units on a scale | Pentoxifylline and Tocopherol | CONTROL |
|---|---|---|
| 1 month of starting treatment | 14.5 (13.2 to 15.8) | 15.5 (14 to 17) |
| 3 month of starting treatment | 14 (13 to 15) | 15.5 (14 to 17) |
| 6 month of starting treatment | 14 (13 to 15) | 15.5 (14 to 17) |
| 9 month of starting treatment | 13.3 (12 to 14.6) | 15.5 (14 to 17) |
Collected over 18 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pentoxifylline and Tocopherol | — | 0/12 (0%) | 0/12 (0%) |
| Control Group | — | 0/12 (0%) | 0/12 (0%) |
| Age, Continuous(years) | Pentoxifylline and Tocopherol | Control Group | Total |
|---|---|---|---|
| Mean | 57 ± 10 | 55 ± 10 | 56 ± 10 |
| Sex: Female, Male(Participants) | Pentoxifylline and Tocopherol | Control Group | Total |
|---|---|---|---|
| Female | 2 | 2 | 4 |
| Male | 10 | 10 | 20 |
| Exposed bone(mm^2) | Pentoxifylline and Tocopherol | Control Group | Total |
|---|---|---|---|
| Mean | 10 ± 10 | 15 ± 10 | 12.5 ± 10 |
Plan to share: Undecided
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Pentoxifylline · Tocopherols
Hospital Vall d'Hebron