MDACC Study Summary S00-00B (Archived)

Study Summary
No. S00-00B:.......Cancer Prevention; Eye; Prostate......Elise D. Cook......Clinical Cancer Prevention

Study Summary Title



Study Summary Number:	S00-00B

Study Title:	Prevention of Cataract and Age-Related Macular Degeneration with Vitamin E and Selenium - SELECT Eye Endpoints (SEE)

Physician

New Patient Referral



Name:	Elise D. Cook	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Clinical Cancer Prevention	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-794-4400 Contact us about clinical trials

General Information



Disease Group:	Cancer Prevention Eye Prostate	Supported By:	Southwest Oncology Group and NCI

Phase of Study:	Phase III	Return Visit:	Every six months per the SELECT protocol.

Treatment Agents:	Alpha-Tocopherol Selenomethionine	Home Care:	N/A

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	n/a


Description/ Intervention:	The goal of this clinical research study is to find out if taking Vitamin E and/or selenium can help to prevent cataracts and AMD.

Study Objectives / Outcomes

The primary and secondary objectives involve the main treatment effect of each study agent on AMD and cataract endpoints.

Primary Objectives
a. To test whether 400 mg of vitamin E reduces the risk of visually-significant AMD.
b. To test whether 200 mcg of selenium reduces the risk of visually-significant AMD.
c. To test whether 400 mg of vitamin E reduces the risk of cataract.
d. To test whether 200 mcg of selenium reduces the risk of cataract.

Secondary Objectives
a. To test whether 400 mg of vitamin E reduces the risk of advanced AMD.
b. To test whether 200 mcg of selenium reduces the risk of advanced AMD.
c. To test whether 400 mg of vitamin E reduces the risk of cataract surgery and subtypes.
d. To test whether 200 mcg of selenium reduces the risk of cataract surgery and subtypes.

Study Status Information



Study Activation / Registration Date:	03/14/2008

IRB Review and Approval Date:	06/09/2009

Study Type:	Phase Iii

Recruitment Status:	Terminated

Projected Accrual:	This a multi-center trial so total accrual is unknown at other sites. While all men in SELECT (about 32,400 men) will submit baseline information about cataracts and AMD approximately 2,150 men may be asked to submit additional medical information about cataract's and 820 men may be asked to submit additional medical information about AMD for this study.

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) The potential S0000B (SEE) participant must be a SELECT participant at the time of registration to SEE. Participants may be registered to SEE at any time after SELECT randomization. Participant are registered only after they report an eye event of interest.

2) The potential participant must report a diagnosis of age-related macular degeneration (AMD) at baseline (contact 010) or at follow-up, OR a diagnosis of cataract or a cataract extraction at follow-up. (Effective November 1, 2009 accrual of new participants based solely on a diagnosis of cataract or a cataract extraction at follow up is closed.)

3) Participant must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines before SEE procedures are initiated. Participants must have signed an applicable medical records release form and it must have been sent to Dr. William Christen at the SELECT eye Endpoints (SEE) Center in Boston, MA by FAX (fax# 617-278-2030) immedicately after registration to SEE.

4) At the time of participant registration, the treating institution's name and ID number must be provided to the Statistical Center in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base.

Exclusion Criteria:

1) A participant who reported a previous diagnosis of cataract at baseline (contact 010), then reports a cataract event (another cataract diagnosis or a cataract extraction) at follow-up, is not eligible.

Links

Registration Number: NCT00784225
Study Information on Clinical Trials Registry (clinicaltrials.gov)