Study record managers: refer to the Data Element Definitions if submitting registration or information.
Flaxseed may reduce the of hot flashes and improve mood and quality of life in postmenopausal women not receiving estrogen therapy. PURPOSE: This randomized phase III trial is studying flaxseed to see how well it works in treating postmenopausal women with hot How to get engaged in a year who have a history of breast cancer or other cancer or who do not wish to take estrogen therapy.
Patients are randomized to 1 of 2 treatment arms.
Patients are contacted by telephone at the end of weeks 2, 4, 5, and 7 to assess Korean dating show jjak tolerability, document compliance, encourage Full body massage in kolkata saltlake of questionnaires, and address problems. The hot flash activity will be measured by the weekly average hot flash score which is a composite entity of both frequency and severity of hot flashes.
The hot flash severities are graded from 1 to 4, ranging from mild, to moderate, to severe to very severe. The daily hot flash score is computed by multiplying the mean grade of severity by the frequency during every 24 hour period. Therefore, a score of zero is the lowest possible score and can be interpreted as having no hot flashes.
The average daily hot flash score during the baseline week was compared to the average daily value during week 7. The primary method of analysis will be the independent sample t-test to examine the change of weekly average hot flash score from baseline to treatment termination between flaxseed and placebo arms. Profile of Mood States POMS was used to look at total mood disturbance as well as the subscales of tension-anxiety, fatigue-inertia, and vigor-activity. The POMS is a well known, well validated, reliable measure of psychological distress which includes 6 subscales of fatigue-inertia, vigor-activity, tension-anxiety, depression-dejection, anger-hostility, and confusion-bewilderment.
The entire scale can be scored to provide a measure of total mood disturbance. The measure contains adjectives related to mood which are Photos of sinusitis from 0 not at all to 4 extremely. Individual scores were converted to a scale where is best quality of life. The change of mood as measured by the POMS from baseline to treatment termination between flaxseed versus placebo Greenville junction ME sexy women was compared using Kruskal-Wallis test. The mean change in total score for each arm is reported.
Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Broken heart stories Studies.
Patients who have been using antidepressants for mood and have been on a stable dose for over a month and meet the eligibility criteria for hot flash frequency and duration are eligible. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or information. Search for terms x.
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First Posted : April 4, Last Update Posted : April 4, Study Description. Detailed Description:.
To evaluate the side effect profile of flaxseed in this population. Arm I: Patients receive oral flaxseed in the form of a bar similar to a granola bar once daily. Arm II: Patients receive oral placebo bar once daily.
In both arms, treatment continues for weeks. Patients in arm II may crossover to receive treatment as in arm I after 6 weeks. FDA Resources. Arms and Interventions.
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Outcome Measures. The of patients reporting grade 3 or higher events are reported in this outcome measure. Greenville junction ME sexy women a full list of all events, please refer to the Adverse Events section of this report. The change in quality of life as measured by the MENQOL from baseline to treatment termination between flaxseed versus placebo arms was evaluated. On a scale, patients were asked to answer questions in in each of 4 domain scores Vasomotor, Psychosocial, Physical, Sexual Scores were converted Sex club in rome a scale where is best QOL.
The change in score from baseline to end of treatment were analyzed separately for each domain. Here we report the mean change in score for each category. The change of daily interference as measured by the HFRDIS from baseline to treatment termination between flaxseed versus placebo arms was evaluated with an independent t-test for continuous data.
On a scale, patients Beautiful couple looking dating Utah asked to describe how hot flashes interfered with 10 different aspects of their life work, social activities, leisure activities, sleep, mood, concentration, relationships with others, sexuality, enjoyment of life and overall quality of life. Scores were converted to a scale where is best QOL. The change in total score from baseline to You are looking i am of treatment was analyzed between the groups using a Kruskal-Wallace test.
Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials. Mary's Regional Cancer Center at St.
Brothel double bay St. More Information. National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services.
Phase 3. Study Type :. Interventional Clinical Trial. Actual Enrollment :. Study Start Date :. Actual Primary Completion Date :. Actual Study Completion Date :. Experimental: Arm I Patients receive oral flaxseed in the form of a bar similar to a granola bar once daily. Dietary Supplement: flaxseed Given orally.
Other: placebo Given orally. Colorado Springs, Colorado, United States, Mary's Hospital and Medical Center. Van Elslander Cancer Center at Playboytv swing episode. John Hospital and Medical Center.
David L. Ruth G. Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center. Wisconsin Rapids, Wisconsin, United States, August 11, Key Record Dates. Neoplasms Breast Diseases Skin Diseases.