Menopause Clinical Trial
Official title:
MsFLASH-02: Interventions for Relief of Menopausal Symptoms: A 3-by-2 Factorial Design Examining Yoga, Exercise, and Omega-3 Supplementation
Verified date | August 2014 |
Source | Fred Hutchinson Cancer Research Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
This study is the second clinical trial to be conducted by the Menopause Strategies -
Finding Lasting Answers for Symptoms and Health (MsFLASH) research network, a group of
investigators conducting clinical trials designed to find new ways to alleviate the most
common, bothersome symptoms of the menopausal transition.
In this twelve-week clinical trial, 374 women aged 40-62 who are in the late menopausal
transition or postmenopausal and experiencing bothersome hot flashes will be randomized to
one of three behavioral intervention groups: yoga, exercise, or usual activity. All women
will simultaneously be randomized to receive omega-3 supplementation or a matching placebo.
The primary aims of this trial are to compare the magnitude of changes in perceived,
self-reported frequency and bother of vasomotor symptoms (VMS) before and after the
intervention between yoga and the usual activity comparison group, between exercise and the
usual activity comparison group, and between omega-3 fatty acid supplementation or placebo.
The hypotheses to be tested are:
1. Women assigned to yoga will report lower frequency and less VMS bother than women
assigned to the usual activity group at the end of a 12-week study period.
2. Women assigned to aerobic exercise at moderate-vigorous intensity will report lower
frequency and less VMS bother than women assigned to the usual activity group at the
end of a 12-week study period.
3. Women assigned to omega-3 fatty acid supplementation will report lower frequency and
less VMS bother than women assigned to the placebo group at the end of a 12-week study
period.
The omega-3 component of the study is double-blinded. For yoga, exercise, and usual
activity, the outcomes assessors are blinded to the randomization assignments.
Status | Completed |
Enrollment | 355 |
Est. completion date | May 2012 |
Est. primary completion date | May 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 40 Years to 62 Years |
Eligibility |
Inclusion Criteria: - Females aged 40-62 years. - Menopausal, including: - Women who have had a bi-lateral oophorectomy; - Women with a uterus who have skipped 2 or more menstrual cycles with an amenorrhea interval of 60 or more days in the past 12 months; - Women without a uterus and who still have one or both ovaries, with FSH level greater than 20 mIU/mL and estradiol less than or equal to 50 pg/mL; - Women who are using the Mirena IUD or who have had an endometrial ablation and who still have one or both ovaries, with FSH level greater than 20 mIU/mL and estradiol less than or equal to 50 pg/mL. - Having bothersome hot flashes and/or night sweats. - In general good health as determined by medical history, blood pressure, and heart rate: - Absence of uncontrolled hypertension greater than 160/100; - Resting heart rate less than 110 beats per minute;. - No history of myocardial infarction, angina, or cerebrovascular events;. - No history of liver, renal disease, or uncontrolled seizure disorder. - Absence of uncontrolled metabolic disease (such as diabetes) and absence of current infectious disease (such as acute symptoms of mononucleosis) that would put staff and other participants at risk. - Signed informed consent. Exclusion Criteria: - Use of hormone therapy or hormonal contraceptives (with the exception of the Mirena IUD) during the 2 months before enrollment. Vaginal postmenopausal estrogens allowed, with the exception of vaginal creams used more than 3 times a week. - Use of any other therapy that is taken specifically for hot flashes, including prescription, over-the-counter, or herbal therapies, in the past month. - Any current severe or unstable medical illness. - Body mass index (BMI) of 37 or higher, based on measured height and weight. - Severe uncorrected hearing or vision problems. - Current, regular use of anti-coagulants 3 or more times per week, e.g. Coumadin, Heparin, Clopidogrel, aspirin at full dose (due to possible omega-3 supplement interaction). - Drug or alcohol abuse in the past 1 year. - Major severe depressive episode in the past 3 months. - Diagnosis of psychosis or psychotic disorder. - Pregnancy, intending pregnancy, or breastfeeding. - Current participation in another drug trial or intervention study. - Inability or unwillingness to complete the study procedures or interventions. - Physical limitations that limit the ability to participate in yoga or exercise, for example: - Limited mobility (paralyzed, cannot walk 2 blocks); - Back problems (severe spine abnormality, sciatica, prior back surgery, spine fracture in the past 3 months); - musculoskeletal problems that limit the ability to walk on a treadmill or ride a stationary bicycle; - Presence of any absolute contraindications to exercise testing and training, as defined by the American College of Sports Medicine. - Practiced or attended any of the following in the prior 3 months: - Yoga, tai chi, qi gong, or meditation more than one time per week on average; - Aerobic exercise (more than 30 minutes a day on at least 3 days a week); - Inability to achieve 85% of heart rate reserve (HRR; the difference between maximum heart rate and resting heart rate) on graded exercise treadmill test. - Severe allergy to soy (defined as life-threatening reaction to soy that would require medical intervention). - Allergy or sensitivity to fish. - Currently eating 4 or more servings of fish per week. - Currently taking an omega-3 fish oil supplement more than twice per week in the past 4 weeks and unwilling to stop for 12 weeks. Interest women can stop all omega-3 supplements and reevaluate eligibility 4 weeks after stopping the omega-3 supplements. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Indiana University | Indianapolis | Indiana |
United States | Kaiser Division of Research | Oakland | California |
United States | Group Health Research Institute | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Fred Hutchinson Cancer Research Center | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Center for Complementary and Integrative Health (NCCIH), National Institute on Aging (NIA), Nordic Naturals, Office of Research on Women's Health (ORWH) |
United States,
Sternfeld B, LaCroix A, Caan BJ, Dunn AL, Newton KM, Reed SD, Guthrie KA, Booth-LaForce C, Sherman KJ, Cohen L, Freeman MP, Carpenter JS, Hunt JR, Roberts M, Ensrud KE. Design and methods of a multi-site, multi-behavioral treatment trial for menopausal symptoms: the MsFLASH experience. Contemp Clin Trials. 2013 May;35(1):25-34. doi: 10.1016/j.cct.2013.02.009. Epub 2013 Feb 24. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency and bother of hot flashes measured by self-report diaries. | 12 weeks | No | |
Secondary | Frequency of hot flashes measured by objective biological marker. | 12 weeks | No | |
Secondary | Anxiety, health- and menopause-related quality of life, depressed mood, and sleep (subjective by diaries and objective by sleep watch worn on wrist). | 12 weeks | No |
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