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92 Women's health initiative memory study: A trial of the effect of estrogen therapy in preventing dementia
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Abstracts 92
WOMEN’S HEALTH INITIATIVE MEMORY STUDY: A TRIAL OF THE EFFECT OF ESTROGEN THERAPY IN PREVENTING DEMENTIA Beth Melton, Sally Shumaker, Mark Espeland, Steve Rapp, Wendy McBee and Maggie Dailey Bowman Gray School of Medicine Wake Forest University Winston-Salem, North Carolina
Evidence from animal studies, human cross-sectional, case-control, and prospective studies indicate that hormone replacement therapy (HRT) is one of the most promising potential treatments for the delay of symptoms of dementia onset. The Women’s Health Initiative Memory Study (WHIMS) is the first double-blinded, randomized, controlled, long-term clinical trial designed to test the hypothesis that HRT reduces the incidence of all-cause dementia in women age 65 and older. WHIMS, an ancillary study to the Women’s Health Initiative (WI-II), will recruit a subgroup of women age 65 and older from among those enrolling in the Hormone Replacement Trial of the WHI. Approximately 8311 women from 39 WHI Clinical Centers are planned to be recruited over two years. Participants will receive annual cognitive assessment screening using the Modified Mini-Mental (3MS) Examination (Phase I) for four to six years of follow-up. Women experiencing cognitive impairment based on an education and age-adjusted 3MS cutoff score will proceed to Phases II and III for more extensive neuropsychological testing and a neurological evaluation. All women suspected to have dementia will then undergo a series of laboratory tests in order to corroborate the clinical diagnosis and classify the type of dementia (Phase IV). The study is designed to provide greater than 80% statistical power to detect a 40% reduction in the rate of all-cause dementia. Details of the four-phase design and the incorporation of WHIMS into WHI as an ancillary study will be presented. 93 ISSUES IN THE DESIGN OF A MULTICENTER TRIAL COMPARING RADIATION THERAPY TO EXPANDABLE ESOPHAGEAL STENTS FOR PATIENTS WITH ADVANCED UNRESECTABLE ESOPHAGEAL CANCER Carol K. Redmond, Patrick D. Mauldin, Glen L. Portwood, Robert H. Hawes and Peter B. Cotton, for the SORTIE Investigators Medical University of South Carolina Charleston, South Carolina
This presentation will highlight major design issues associated with planning a multicenter randomized clinical trial comparing radiation therapy to expandable esophageal stents in the treatment of patients with advanced unresectable esophageal cancer. This study aims to determine which therapy is more a cost effective in achieving palliation of dysphagia (diffkulty in swallowing). A five point ordinal functional scale will be used to record the dysphagia status for each patient at baseline and prespecified time intervals post randomization, as well as when changes occur in swallowing.capability. Definition of an appropriate endpoint measure to test the primary hypothesis that esophageal stents will be more effective in relieving swallowing difficulties is complicated for several reasons. First, the insertion of an esophageal stent will generally result in an immediate relief of symptoms,
Abstracts 92
WOMEN’S HEALTH INITIATIVE MEMORY STUDY: A TRIAL OF THE EFFECT OF ESTROGEN THERAPY IN PREVENTING DEMENTIA Beth Melton, Sally Shumaker, Mark Espeland, Steve Rapp, Wendy McBee and Maggie Dailey Bowman Gray School of Medicine Wake Forest University Winston-Salem, North Carolina
Evidence from animal studies, human cross-sectional, case-control, and prospective studies indicate that hormone replacement therapy (HRT) is one of the most promising potential treatments for the delay of symptoms of dementia onset. The Women’s Health Initiative Memory Study (WHIMS) is the first double-blinded, randomized, controlled, long-term clinical trial designed to test the hypothesis that HRT reduces the incidence of all-cause dementia in women age 65 and older. WHIMS, an ancillary study to the Women’s Health Initiative (WI-II), will recruit a subgroup of women age 65 and older from among those enrolling in the Hormone Replacement Trial of the WHI. Approximately 8311 women from 39 WHI Clinical Centers are planned to be recruited over two years. Participants will receive annual cognitive assessment screening using the Modified Mini-Mental (3MS) Examination (Phase I) for four to six years of follow-up. Women experiencing cognitive impairment based on an education and age-adjusted 3MS cutoff score will proceed to Phases II and III for more extensive neuropsychological testing and a neurological evaluation. All women suspected to have dementia will then undergo a series of laboratory tests in order to corroborate the clinical diagnosis and classify the type of dementia (Phase IV). The study is designed to provide greater than 80% statistical power to detect a 40% reduction in the rate of all-cause dementia. Details of the four-phase design and the incorporation of WHIMS into WHI as an ancillary study will be presented. 93 ISSUES IN THE DESIGN OF A MULTICENTER TRIAL COMPARING RADIATION THERAPY TO EXPANDABLE ESOPHAGEAL STENTS FOR PATIENTS WITH ADVANCED UNRESECTABLE ESOPHAGEAL CANCER Carol K. Redmond, Patrick D. Mauldin, Glen L. Portwood, Robert H. Hawes and Peter B. Cotton, for the SORTIE Investigators Medical University of South Carolina Charleston, South Carolina
This presentation will highlight major design issues associated with planning a multicenter randomized clinical trial comparing radiation therapy to expandable esophageal stents in the treatment of patients with advanced unresectable esophageal cancer. This study aims to determine which therapy is more a cost effective in achieving palliation of dysphagia (diffkulty in swallowing). A five point ordinal functional scale will be used to record the dysphagia status for each patient at baseline and prespecified time intervals post randomization, as well as when changes occur in swallowing.capability. Definition of an appropriate endpoint measure to test the primary hypothesis that esophageal stents will be more effective in relieving swallowing difficulties is complicated for several reasons. First, the insertion of an esophageal stent will generally result in an immediate relief of symptoms,