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| ID | Type | Description | Link |
|---|---|---|---|
| S0000B | Other Identifier | SWOG | |
| U10CA037429 | U.S. NIH Grant/Contract | View source | |
| R01EY014418 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| National Eye Institute (NEI) | NIH |
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RATIONALE: Aging may affect a person's vision. Vitamin E and/or selenium may help prevent cataracts or age-related macular degeneration in men receiving these drugs as part of a clinical trial for the prevention of prostate cancer.
PURPOSE: This clinical trial is studying vitamin E and/or selenium to see how well they work in preventing cataract and age-related macular degeneration in men enrolled on SELECT (SWOG-S0000).
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Data from medical records obtained from the participant's ophthalmologist or optometrist are reviewed. Information from these records is then used to confirm baseline reports of age-related macular degeneration (AMD) as well as 6-month and annual reports of new diagnoses of AMD and cataract (or cataract surgery) made since the start of this study. Detailed questionnaires are also obtained from the participant's ophthalmologist or optometrist to provide information about the reported AMD or cataract diagnosis (e.g., date of initial diagnosis; best-corrected visual acuity at the time of diagnosis; date when visual acuity was first noted to be 20/30 or worse [if different from the date of initial diagnosis]; pathological findings observed when AMD was first diagnosed [e.g., drusen, retinal pigment epithelial hypo/hyperpigmentation, geographic atrophy, retinal pigment epithelial detachment, subretinal neovascular membrane, or disciform scar]; pathological findings observed when visual acuity was first noted to be 20/30 or worse; date when exudative [wet] AMD was first noted; presence of other ocular abnormalities that could explain or contribute to visual loss; whether AMD or cataract, by itself, are significant enough to cause vision to be reduced to 20/30 or worse; whether laser treatment or photodynamic therapy was performed for AMD; date of cataract extraction; etiology of cataract [e.g., age-related, traumatic, congenital, inflammatory, or surgery- or steroid-induced]; and cataract type [e.g., nuclear, cortical, posterior subcapsular, or other]).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin E + selenium placebo | Experimental | vitamin E and selenium placebo daily for 7-12 years |
|
| Selenium + vitamin E placebo | Experimental | selenium and vitamin E placebo daily for 7-12 years |
|
| Vitamin E + selenium | Experimental | vitamin E and selenium placebo daily for 7-12 years |
|
| Vitamin E placebo + selenium placebo | Placebo Comparator | vitamin E placebo and selenium placebo daily for 7-12 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| selenium | Drug | 200 mcg daily for 7-12 years |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Visually Significant Age-related Macular Degeneration (AMD) | Visually significant age-related AMD was defined as incident AMD responsible for reduction in best corrected visual acuity to 20/30 or worse(AMD 20/30) | Every 6 months, up to 7 years |
| Number of Participants With Cataract and Best Corrected Visual-acuity of 20/30 | Incident cataract was defined as lens opacity diagnosed after randomization but prior to end of study, age-related in origin, and best-corrected visual acuity of 20/30 or worse attributable to the opacity. | Every 6 months, up to 7 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Advanced AMD | Advanced AMD was defined as the occurrence of disciform scars, or geographic atrophy or retinal pigment epithelium (RPE) detachment in either or both eyes at AMD diagnosis. | Every 6 months, up to 7 years |
| Number of Participants Who Underwent Cataract Extraction |
Not provided
DISEASE CHARACTERISTICS:
Enrolled on the Selenium and Vitamin E Prostate Cancer Prevention Trial (SELECT) SWOG-S0000
Diagnosis of 1 of the following:
Age-related macular degeneration (AMD) at baseline or at follow-up
Cataract or a cataract extraction at follow-up (Closed for accrual as of 10/01/29)
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| William Christen, ScD | Dana-Farber/Brigham and Women's Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harvard Medical School | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27519183 | Derived | Goodman PJ, Tangen CM, Darke AK, Arnold KB, Hartline J, Yee M, Anderson K, Caban-Holt A, Christen WG, Cassano PA, Lance P, Klein EA, Crowley JJ, Minasian LM, Meyskens FL. Opportunities and challenges in incorporating ancillary studies into a cancer prevention randomized clinical trial. Trials. 2016 Aug 12;17:400. doi: 10.1186/s13063-016-1524-9. | |
| 25232809 | Derived | Christen WG, Glynn RJ, Gaziano JM, Darke AK, Crowley JJ, Goodman PJ, Lippman SM, Lad TE, Bearden JD, Goodman GE, Minasian LM, Thompson IM Jr, Blanke CD, Klein EA. Age-related cataract in men in the selenium and vitamin e cancer prevention trial eye endpoints study: a randomized clinical trial. JAMA Ophthalmol. 2015 Jan;133(1):17-24. doi: 10.1001/jamaophthalmol.2014.3478. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Selenium + Vitamin E Placebo | Patients received selenium and vitamin E placebo daily for 7 - 12 years Selenium: 200 mcg daily for 7 - 12 years Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years |
| FG001 | Selenium + Vitamin E |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Oct 19, 2009 |
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| vitamin E | Drug | 400 IU daily by mouth for 7-12 years |
|
|
| vitamin E placebo | Drug | daily for 7-12 years |
|
|
| selenium placebo | Drug | daily for 7-12 years |
|
|
Cataract extraction was defined as the surgical removal of an incident cataract. |
| Every 6 months, up to 7 years |
Patients received selenium and vitamin E daily for 7 - 12 years
Selenium: 200 mcg 1 pill by mouth daily for 7 - 12 years
Vitamin E: 400 IU daily by mouth for 7 - 12 years
| FG002 | Vitamin E Placebo + Selenium Placebo | Patients received vitamin E placebo and selenium placebo daily for 7 - 12 years Vitamin E placebo:1 pill daily by mouth for 7 - 12 years Selenium placebo: 1 pill by mouth daily for 7 - 12 years |
| FG003 | Vitamin E + Selenium Placebo | Patients received vitamin E and selenium placebo daily for 7 - 12 years Vitamin E: 400 IU by mouth daily for 7 - 12 years Selenium placebo: 1 pill by mouth daily for 7 - 12 years |
| COMPLETED |
|
| NOT COMPLETED |
|
Participants at SELECT sites with IRB approval for SEE and who agreed to participate in SEE or were willing to be contacted about registering to SEE if they were to have an eye event were registered to AMD (13389) and Cataract (11267) portions. There was overlap between the two populations.
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| ID | Title | Description |
|---|---|---|
| BG000 | Selenium + Vitamin E Placebo | Selenium and vitamin E placebo daily for 7-12 years. Selenium: 200 mcg daily for 7 - 12 years Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years |
| BG001 | Selenium + Vitamin E | Selenium and vitamin E daily for 7-12 years. Selenium: 200 mcg daily for 7 - 12 years Vitamin E: 400 IU daily by mouth for 7 - 12 years |
| BG002 | Vitamin E Placebo + Selenium Placebo | Vitamin E placebo and selenium placebo daily for 7-12 years. Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years Selenium placebo: 1 pill by mouth daily for 7 - 12 years |
| BG003 | Vitamin E + Selenium Placebo | Vitamin E and selenium placebo daily for 7-12 years. Vitamin E: 400 IU daily by mouth for 7 - 12 years Selenium placebo: 1 pill by mouth daily for 7 - 12 years |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Education (highest level) | Count of Participants | Participants |
| ||||||||||||||||
| Cigarette smoking | Count of Participants | Participants |
| ||||||||||||||||
| Alcohol use | Count of Participants | Participants |
| ||||||||||||||||
| Body mass index (kg/m^2) | Count of Participants | Participants |
| ||||||||||||||||
| History of hypertension | Count of Participants | Participants |
| ||||||||||||||||
| Aspirin use | Count of Participants | Participants |
| ||||||||||||||||
| Statin use | Count of Participants | Participants |
| ||||||||||||||||
| History of diabetes | Count of Participants | Participants |
| ||||||||||||||||
| Records sought | Participants were asked to consent to participate in S0000B, which required them to complete a medical release with information about their ophthalmologic provider. Using this information, Providers were sent a form to complete describing the cataract/cataract extraction/AMD (as applicable) in detail. | Count of Participants | Participants |
| |||||||||||||||
| Included in cataract analysis | Count of Participants | Participants |
| ||||||||||||||||
| Included in AMD analysis | Count of Participants | Participants |
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| 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 Visually Significant Age-related Macular Degeneration (AMD) | Visually significant age-related AMD was defined as incident AMD responsible for reduction in best corrected visual acuity to 20/30 or worse(AMD 20/30) | Marginal analyses were performed with arms pooled based on active vs. placebo selenium or vitamin E. | Posted | Count of Participants | Participants | Every 6 months, up to 7 years |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Cataract and Best Corrected Visual-acuity of 20/30 | Incident cataract was defined as lens opacity diagnosed after randomization but prior to end of study, age-related in origin, and best-corrected visual acuity of 20/30 or worse attributable to the opacity. | Marginal analyses were performed with arms pooled based on active vs. placebo selenium or vitamin E. | Posted | Count of Participants | Participants | Every 6 months, up to 7 years |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Advanced AMD | Advanced AMD was defined as the occurrence of disciform scars, or geographic atrophy or retinal pigment epithelium (RPE) detachment in either or both eyes at AMD diagnosis. | Marginal analyses were performed with arms pooled based on active vs. placebo selenium or vitamin E. | Posted | Count of Participants | Participants | Every 6 months, up to 7 years |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Underwent Cataract Extraction | Cataract extraction was defined as the surgical removal of an incident cataract. | Marginal analyses were performed with arms pooled based on active vs. placebo selenium or vitamin E. | Posted | Count of Participants | Participants | Every 6 months, up to 7 years |
|
Every 6 months while the participant is receiving study supplements, up to 7 years
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
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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 | Selenium + Vitamin E Placebo | Selenium + Vitamin E placebo | 151 | 3,374 | 44 | 3,374 | 243 | 3,374 |
| EG001 | Selenium + Vitamin E | Selenium + Vitamin E | 159 | 3,356 | 41 | 3,356 | 243 | 3,356 |
| EG002 | Placebo | Placebo | 150 | 3,366 | 50 | 3,366 | 261 | 3,366 |
| EG003 | Vitamin E + Selenium Placebo | Vitamin E + Selenium placebo | 147 | 3,374 | 45 | 3,374 | 267 | 3,374 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia, NOS | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Cardiac ischemia/infarction | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Cardiovascular-other | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Conduction abnormality/block | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| LVEF decrease/CHF | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Supraventricular arrhythmia | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Eye-other | Eye disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Vision,NOS | Eye disorders | CTCAE (2.0) | Systematic Assessment |
| |
| GI-other | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Melena/ GI bleeding | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Constitutional symptoms-other | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hemorrhage w/o 3-4 thrombocyt | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Reportable adverse event, NOS | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Liver-clinical | Hepatobiliary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Respiratory infect w/o neutrop | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Respiratory infection, unk ANC | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Surgery-hemorrhage | Injury, poisoning and procedural complications | CTCAE (2.0) | Systematic Assessment |
| |
| Weight gain | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Second primary | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (2.0) | Systematic Assessment |
| |
| CNS hemorrhage | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Cerebrovascular ischemia | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Seizures | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Sensory neuropathy | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Emphysema/COPD | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Carotid stenosis | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Peripheral arterial ischemia | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Thrombosis/embolism | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac ischemia/infarction | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| SELECT/S0000B Statistician | SWOG Statistical Center | 2066674623 | adarke@fredhutch.org |
| May 10, 2019 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D002386 | Cataract |
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
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| ID | Term |
|---|---|
| D012643 | Selenium |
| D014810 | Vitamin E |
| D024502 | alpha-Tocopherol |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008903 | Minerals |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D024505 | Tocopherols |
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| 55-64 years |
|
| 65-74 years |
|
| >=75 years |
|
| Male |
|
| Non-white |
|
| Some college/vocational school |
|
| >College graduate |
|
| Unknown/missing |
|
| Current |
|
| Former |
|
| Unknown |
|
| >=1 drink/month |
|
| Unknown |
|
| 25-<30 |
|
| >=30 |
|
| No |
|
| No |
|
| No |
|
| Unknown |
|
| No |
|
| No |
|
| No |
|
| No |
|
| non-AMD cases |
|
| Regression, Cox |
| 0.51 |
| Cox Proportional Hazard |
| 0.75 |
| 2-Sided |
| 95 |
| 0.31 |
| 1.77 |
| Superiority |
| OG003 | Cataract: Vitamin E Placebo | Patients received vitamin E placebo and either selenium or selenium placebo daily for 7 - 12 years Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years Selenium: 200 mcg daily for 7 - 12 years Selenium placebo: 1 pill by mouth daily for 7 - 12 years |
|
|
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| OG003 | AMD: Vitamin E Placebo | Patients received vitamin E placebo and either selenium or selenium placebo daily for 7 - 12 years Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years Selenium: 200 mcg daily for 7 - 12 years Selenium placebo: 1 pill by mouth daily for 7 - 12 years |
|
|
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| OG003 | Cataract: Vitamin E Placebo | Patients received vitamin E placebo and either selenium or selenium placebo daily for 7 - 12 years Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years Selenium: 200 mcg daily for 7 - 12 years Selenium placebo: 1 pill by mouth daily for 7 - 12 years |
|
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