MsFLASH-02: Interventions for Relief of Menopausal Symptoms: A 3-by-2 Factorial Design Examining Yoga, Exercise, and Omega-3 Supplementation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hot Flashes
- Sponsor
- Fred Hutchinson Cancer Center
- Enrollment
- 355
- Locations
- 3
- Primary Endpoint
- Frequency and bother of hot flashes measured by self-report diaries.
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
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:
- 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.
- 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.
- 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.
Detailed Description
Over 33 million U.S. women will transition through menopause in the next decade. Among women with natural menopause, the transition typically lasts four years, with a mean age at menopause of 51 years. Menstrual irregularity (90%) and vasomotor symptoms (VMS) (80%) are the most common symptoms associated with the transition. Hormone therapy has been the gold standard for treating VMS symptoms against which other therapies are measured. However, resistance to hormone therapy use due to its risks and side effects continues to fuel the search for safer alternatives. This research study will evaluate three low risk interventions (yoga, exercise, and omega-3 supplements) compared to either a usual activity group or a placebo pill. This factorial design is motivated by the desire to have all women receive some intervention. Neither comparisons between yoga and exercise nor tests of interaction between the behavioral interventions (yoga, exercise, usual activity) and omega-3 motivated this design. However, these aspects can be examined in secondary analyses in a more rigorous fashion through this design than would be permitted by separate trials.
Investigators
Eligibility Criteria
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;.
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.
Outcomes
Primary Outcomes
Frequency and bother of hot flashes measured by self-report diaries.
Time Frame: 12 weeks
Secondary Outcomes
- Frequency of hot flashes measured by objective biological marker.(12 weeks)
- 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)