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This study seeks to determine if a combination of Trental and Vitamin E prevents the development of radiation fibrosis in women treated with radiation for the definitive management of their breast cancer.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | No Intervention | Control for study - watchful waiting. | |
| 2 | Experimental | Combined treatment with Pentoxifylline and Vitamin E. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pentoxifylline | Drug | Pentoxifylline 400 mg, 3 times daily for 7 months, beginning immediately after radiation therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjective, Objective, Management, and Analytic (SOMA) Score | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Tissue Compliance | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Geraldine Jacobson, MD MPH | department of radiation oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Iowa Hospitals & Clinics | Iowa City | Iowa | 52242 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2394619 | Background | 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. | |
| 10506631 | Background | 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. |
| Label | URL |
|---|---|
| Article abstract | View source |
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Between April 2003 and July 2009, 53 breast cancer patients were recruited from the University of Iowa Radiation Oncology clinic and randomized to one of two arms.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Arm | Watchful waiting (standard treatment). Study participants received no intervention and were monitored for development of radiation-induced fibrosis. |
| FG001 | Intervention: Pentoxifylline & Vitamin E | Combined treatment with Pentoxifylline and Vitamin E. Vitamin E : Vitamin E (Over-the-counter) 400 I.U. once daily Pentoxifylline : Pentoxifylline 400 mg, 3 times daily for 7 months, beginning immediately after radiation therapy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Arm | Watchful waiting (standard treatment). Study participants received no intervention and were monitored for development of radiation-induced fibrosis. |
| BG001 | Intervention: Pentoxifylline & Vitamin E |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Subjective, Objective, Management, and Analytic (SOMA) Score | 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. | All participants enrolled in the study were evaluated for SOMA scores. Numbers varied by study participants compliance with follow-up appointments. | Posted | Mean | Standard Deviation | units on a scale | 18 month post-treatment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Arm | Watchful waiting (standard treatment). Study participants received no intervention and were monitored for development of radiation-induced fibrosis. |
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Small, single-institutional study. Smaller clinical trials are prone to imbalances in patient characteristics across treatment arms. t tests applied to small studies can be unduly influenced by data that contain outliers or are skewed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Geraldine Jacobson, MD, MBA, MPH, FACR | West Virginia University | (304) 293-7227 | GMJACOBSON@hsc.wvu.edu |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D010431 | Pentoxifylline |
| D014810 | Vitamin E |
| ID | Term |
|---|---|
| D013805 | Theobromine |
| D014970 | Xanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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| Vitamin E | Drug | Vitamin E (Over-the-counter) 400 I.U. once daily |
|
| 18 months post-treatment |
| 12829674 | Background | 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. |
| 15542159 | Background | 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. |
| 16260695 | Background | 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. |
Combined treatment with Pentoxifylline and Vitamin E.
Vitamin E : Vitamin E (Over-the-counter) 400 I.U. once daily
Pentoxifylline : Pentoxifylline 400 mg, 3 times daily for 7 months, beginning immediately after radiation therapy.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Combined treatment with Pentoxifylline and Vitamin E. Vitamin E : Vitamin E (Over-the-counter) 400 I.U. once daily Pentoxifylline : Pentoxifylline 400 mg, 3 times daily for 7 months, beginning immediately after radiation therapy. |
|
|
| Secondary | Tissue Compliance | 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. | All study participants enrolled were to be measured at 18 months post-radiotherapy. The number of participants analyzed varied by the number compliant with study schedule. | Posted | Mean | Standard Deviation | milimeters (mm) | 18 months post-treatment |
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | Intervention: Pentoxifylline & Vitamin E | Combined treatment with Pentoxifylline and Vitamin E. Vitamin E : Vitamin E (Over-the-counter) 400 I.U. once daily Pentoxifylline : Pentoxifylline 400 mg, 3 times daily for 7 months, beginning immediately after radiation therapy. | 0 | 27 | 0 | 27 |
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| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |