- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00583700
Trental & Vitamin E for Radiation-Induced Fibrosis
Development of Radiation Fibrosis in Patients Treated With Pentoxyphylline and Vitamin E: a Prospective Randomized Study
Study Overview
Detailed Description
Radiation fibrosis occurs in approximately 25% of those women treated with radiation for breast cancer. Of these, approximately 3 to 5% will develop into an acute, painful form of fibrosis. Mild fibrosis can present as a thicker or more dense breast where the acute form can cause pain in the breast, significant hardening, and inflammation.
Treatments for fibrosis are lacking, with the primary treatment being hyperbaric oxygen therapy. The combination of Trental & Vitamin E has been used with success in Europe and at the University of Iowa.
The focus of this study is to prevent fibrosis through intervention with Trental & Vitamin E. The study has two arms, a control arm and an intervention arm. The study is not blinded. Measurements are taken at standard follow-up visits to measure breast density and lymphedema.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Iowa
-
Iowa City, Iowa, United States, 52242
- The University of Iowa Hospitals & Clinics
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with histologically documented cancer of the breast or DCIS or head and neck referred for definitive radiation with curative intent.
- No evidence of metastatic disease.
- Minimum life expectancy of at least 12 months.
- Aged greater than 20 years.
- If female, pregnancy excluded.
- No documented history of collagen vascular disease.
Exclusion Criteria:
- Cognitively impaired patients
- Prisoners
- No histology available
- Documented metastatic disease
- Allergy to Trental
- Life expectance of less than 12 months.
- Aged less than 20 years
- Collagen vascular disease present
- Pregnant
- History of liver disease
- Use of anticoagulants
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: 1
Control for study - watchful waiting.
|
|
Experimental: 2
Combined treatment with Pentoxifylline and Vitamin E.
|
Pentoxifylline 400 mg, 3 times daily for 7 months, beginning immediately after radiation therapy.
Other Names:
Vitamin E (Over-the-counter) 400 I.U.
once daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjective, Objective, Management, and Analytic (SOMA) Score
Time Frame: 18 month post-treatment
|
A primary outcome of interest is the composite Subjective, Objective, Management, and Analytic (SOMA) score at 18-month follow-up visit.
Maximum score is 45, with a score of 0 being ideal and representing no treatment-related side effects at the study visit.
|
18 month post-treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tissue Compliance
Time Frame: 18 months post-treatment
|
Tissue compliance meter measurements of the treated breast compared to the non-treated breast were obtained at 18 months post-radiation therapy. Tissue compliance simply means how soft and pliable the breast tissue is when force is applied to it. One physician would hold the tissue compliance meter (TCM) against the participant's skin. A standard amount of force would be applied. A second physician would read the displacement scale for a specific set of areas on the breast. The range of the scale was 0 to 60 milimeters (mm). The physician's were blineded to the participant's intervention at the time of measurement. The final value is the difference between the untreated and the treated breast [untreated - treated]. The range of these differences was -3.3 to 7.0 mm. |
18 months post-treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Geraldine Jacobson, MD MPH, department of radiation oncology
Publications and helpful links
General Publications
- Dion MW, Hussey DH, Doornbos JF, Vigliotti AP, Wen BC, Anderson B. Preliminary results of a pilot study of pentoxifylline in the treatment of late radiation soft tissue necrosis. Int J Radiat Oncol Biol Phys. 1990 Aug;19(2):401-7. doi: 10.1016/0360-3016(90)90549-y.
- Delanian S, Balla-Mekias S, Lefaix JL. Striking regression of chronic radiotherapy damage in a clinical trial of combined pentoxifylline and tocopherol. J Clin Oncol. 1999 Oct;17(10):3283-90. doi: 10.1200/JCO.1999.17.10.3283.
- Delanian S, Porcher R, Balla-Mekias S, Lefaix JL. Randomized, placebo-controlled trial of combined pentoxifylline and tocopherol for regression of superficial radiation-induced fibrosis. J Clin Oncol. 2003 Jul 1;21(13):2545-50. doi: 10.1200/JCO.2003.06.064.
- Gothard L, Cornes P, Earl J, Hall E, MacLaren J, Mortimer P, Peacock J, Peckitt C, Woods M, Yarnold J. Double-blind placebo-controlled randomised trial of vitamin E and pentoxifylline in patients with chronic arm lymphoedema and fibrosis after surgery and radiotherapy for breast cancer. Radiother Oncol. 2004 Nov;73(2):133-9. doi: 10.1016/j.radonc.2004.09.013.
- Delanian S, Porcher R, Rudant J, Lefaix JL. Kinetics of response to long-term treatment combining pentoxifylline and tocopherol in patients with superficial radiation-induced fibrosis. J Clin Oncol. 2005 Dec 1;23(34):8570-9. doi: 10.1200/JCO.2005.02.4729. Epub 2005 Oct 31.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Fibrosis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Enzyme Inhibitors
- Platelet Aggregation Inhibitors
- Protective Agents
- Micronutrients
- Vitamins
- Antioxidants
- Phosphodiesterase Inhibitors
- Free Radical Scavengers
- Radiation-Protective Agents
- Vitamin E
- Pentoxifylline
Other Study ID Numbers
- 200211003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Fibrosis
-
Peking Union Medical College HospitalRecruitingIdiopathic Retroperitoneal FibrosisChina
-
San Gerardo HospitalCompletedIdiopathic Pulmonary Fibrosis | Cardiac Fibrosis | Arterial FibrosisItaly
-
St. Antonius HospitalZonMw: The Netherlands Organisation for Health Research and Development; Boeringer...RecruitingPulmonary Fibrosis Idiopathic FamilialNetherlands
-
Assistance Publique - Hôpitaux de ParisRecruitingIdiopathic Retroperitoneal FibrosisFrance
-
Peking Union Medical College HospitalRecruitingIdiopathic Retroperitoneal FibrosisChina
-
University of ParmaUnknownIdiopathic Retroperitoneal Fibrosis | Perianeurysmal Retroperitoneal Fibrosis | Chronic PeriaortitisItaly
-
Peking Union Medical College HospitalRecruiting
-
Peking Union Medical College HospitalRecruiting
-
Hospital de Clinicas de Porto AlegreUnknownCystic Fibrosis | Cystic Fibrosis Pulmonary Exacerbation | Cystic Fibrosis in Children | Cystic Fibrosis With ExacerbationBrazil
-
University Hospital, GrenobleNot yet recruiting
Clinical Trials on Pentoxifylline
-
Hospital Universitario de CanariasUnknown
-
Beijing Tiantan HospitalCSPC Ouyi Pharmaceutical Co., Ltd.Not yet recruitingCerebral Small Vessel DiseasesChina
-
Institute of Liver and Biliary Sciences, IndiaUnknown
-
Assistance Publique - Hôpitaux de ParisMerck Sharp & Dohme LLCCompletedBenign Prostatic Hyperplasia (BPH) Requiring Surgical ResectionFrance
-
Hospital Universitario de CanariasInstituto Médico Tinerfeño IMETISAUnknown
-
Alexandria UniversityNot yet recruiting
-
National Cancer Institute (NCI)CompletedFibrosis | Radiation InjuriesUnited States
-
National Taiwan University HospitalCompletedPrimary GlomerulonephritisTaiwan
-
University of MichiganCompletedAcute Kidney FailureUnited States