Fibrosis
Conditions
Keywords
Breast Neoplasms, Radiotherapy
Brief summary
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.
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.
Interventions
DRUGPentoxifylline
Pentoxifylline 400 mg, 3 times daily for 7 months, beginning immediately after radiation therapy.
DRUGVitamin E
Vitamin E (Over-the-counter) 400 I.U. once daily
Sponsors
University of Iowa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective, Objective, Management, and Analytic (SOMA) Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tissue Compliance | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Control Arm Watchful waiting (standard treatment). Study participants received no intervention and were monitored for development of radiation-induced fibrosis. | 27 |
| 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. | 27 |
| Total | 54 |
Baseline characteristics
| Characteristic | Intervention: Pentoxifylline & Vitamin E | Control Arm | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 2 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 25 Participants | 43 Participants |
| Age Continuous | 59.65 years STANDARD_DEVIATION 11.74 | 54.7 years STANDARD_DEVIATION 10.81 | 56.81 years STANDARD_DEVIATION 11.54 |
| Region of Enrollment United States | 27 participants | 27 participants | 54 participants |
| Sex: Female, Male Female | 27 Participants | 27 Participants | 54 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 27 | 0 / 27 |
| serious Total, serious adverse events | 0 / 27 | 0 / 27 |
Outcome results
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.
Time frame: 18 month post-treatment
Population: All participants enrolled in the study were evaluated for SOMA scores. Numbers varied by study participants compliance with follow-up appointments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Arm | Subjective, Objective, Management, and Analytic (SOMA) Score | 1.59 units on a scale | Standard Deviation 1.53 |
| Intervention: Pentoxifylline & Vitamin E | Subjective, Objective, Management, and Analytic (SOMA) Score | 1.0 units on a scale | Standard Deviation 1.19 |
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.
Time frame: 18 months post-treatment
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Arm | Tissue Compliance | 2.10 milimeters (mm) | Standard Deviation 2.16 |
| Intervention: Pentoxifylline & Vitamin E | Tissue Compliance | 0.88 milimeters (mm) | Standard Deviation 1.96 |