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The purpose of this study is to determine whether the use of Trental and Vitamin E can help reduce the incidence of radiation necrosis (a lesion that usually occurs at the original tumor site) after radiosurgery. These two drugs are commonly used to treat radiation necrosis when it occurs but the hope is that these drugs can be used to prevent radiation necrosis from ever occurring.
The treatment phase of the study is 6 months. Study procedures will be conducted such as: history, physical and neurological exam, pregnancy testing (for women of child bearing age) and a Brain MRI. Follow-up appointments will be every 3 months for 1 year at which time, your participation in the study will be concluded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trental + Vitamin E | Experimental | Trental 400 mg TID and Vitamin E 400IU BID starting the first day after the last radiosurgery treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trental | Drug | 400 mg tid starting first day after last radiosurgery treatment and continuing for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Symptomatic Radiation Necrosis | Number of symptomatic death of healthy tissue caused by radiation therapy. | average 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald Warnick, MD | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cincinnati | Cincinnati | Ohio | 45219 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Trental + Vitamin E | Trental 400 mg TID and Vitamin E 400IU BID starting the first day after the last radiosurgery treatment Trental: 400 mg tid starting first day after last radiosurgery treatment and continuing for 6 months Vitamin E: 400IU twice daily starting the first day after last radiosurgery treatment and continuing for 6 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Trental + Vitamin E | Trental 400 mg TID and Vitamin E 400IU BID starting the first day after the last radiosurgery treatment Trental: 400 mg tid starting first day after last radiosurgery treatment and continuing for 6 months Vitamin E: 400IU twice daily starting the first day after last radiosurgery treatment and continuing for 6 months |
| 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 | Number of Participants With Symptomatic Radiation Necrosis | Number of symptomatic death of healthy tissue caused by radiation therapy. | Posted | Count of Participants | Participants | average 1 year |
|
|
Adverse Event collection is not specifically mapped out per protocol. The length of the study is 3 years, thus AE collection is up to three years starting from consent.
Adverse events were not systematically collected for all subjects.
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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 | Trental + Vitamin E | Trental 400 mg TID and Vitamin E 400IU BID starting the first day after the last radiosurgery treatment Trental: 400 mg tid starting first day after last radiosurgery treatment and continuing for 6 months Vitamin E: 400IU twice daily starting the first day after last radiosurgery treatment and continuing for 6 months |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alison Kastl | University of Cincinnati | 513-584-0436 | Kastla@ucmail.uc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 25, 2012 | Jul 12, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| 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 | Dietary Supplement | 400IU twice daily starting the first day after last radiosurgery treatment and continuing for 6 months |
|
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 15 |
| 31 |
| 0 |
| 31 |
| 4 |
| 31 |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Gait disturbance | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Generalized weakness | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Leg swelling | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Lower back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Orthostatic dizziness | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pain in shoulder | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Right leg weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Sleep disturbance | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Weight loss | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Depression | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Diaphoresis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
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| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |