Trial · NCT00583700
Trental & Vitamin E for Radiation-Induced Fibrosis
NCT00583700, Phase 2, Completed, University of Iowa; results first posted 2013-01-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trental & Vitamin E for Radiation-Induced Fibrosis. Trials, record NCT00583700. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00583700
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trental & Vitamin E for Radiation-Induced Fibrosis
- NCT number
- NCT00583700
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 54 participants, actual
- Lead sponsor
- University of Iowa
- Conditions
- Fibrosis
- Interventions
- Pentoxifylline, Vitamin E
- First posted
- 2007-12-31
- Last updated
- 2013-01-29
- Results first posted
- 2013-01-29
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Subjective, Objective, Management, and Analytic (SOMA) Score | 18 month post-treatment | All participants enrolled in the study were evaluated for SOMA scores. Numbers varied by study participants compliance with follow-up appointments. | units on a scale | MEAN |
| SECONDARY | Tissue Compliance | 18 months post-treatment | 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. | milimeters (mm) | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Subjective, Objective, Management, and Analytic (SOMA) Score | Control Arm | 1.59 | Standard Deviation 1.53 | units on a scale | |
| Subjective, Objective, Management, and Analytic (SOMA) Score | Intervention: Pentoxifylline & Vitamin E | 1.0 | Standard Deviation 1.19 | units on a scale | |
| Tissue Compliance | Control Arm | 2.10 | Standard Deviation 2.16 | milimeters (mm) | |
| Tissue Compliance | Intervention: Pentoxifylline & Vitamin E | 0.88 | Standard Deviation 1.96 | milimeters (mm) |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Control Arm | 27 | |
| Overall Study | STARTED | Intervention: Pentoxifylline & Vitamin E | 27 | |
| Overall Study | COMPLETED | Control Arm | 24 | |
| Overall Study | COMPLETED | Intervention: Pentoxifylline & Vitamin E | 23 | |
| Overall Study | NOT COMPLETED | Control Arm | 3 | |
| Overall Study | NOT COMPLETED | Intervention: Pentoxifylline & Vitamin E | 4 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Control Arm | ||
| Total, all-cause mortality | Intervention: Pentoxifylline & Vitamin E | ||
| Total, other adverse events | Control Arm | 0 | 27 |
| Total, other adverse events | Intervention: Pentoxifylline & Vitamin E | 0 | 27 |
| Total, serious adverse events | Control Arm | 0 | 27 |
| Total, serious adverse events | Intervention: Pentoxifylline & Vitamin E | 0 | 27 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Intervention: Pentoxifylline & Vitamin E vs Control Arm: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00583700
GET https://conductscience.org/api/trials/v1/NCT00583700/registered