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MsFLASH02: Interventions for Relief of Menopausal Symptoms: A 3-by-2 Factorial Design Examining Yoga, Exercise, and Omega-3 Supplementation

40 Years
62 Years
Not Enrolling
Hot Flashes, Menopause, Vasomotor Symptoms

Thank you

Trial Information

MsFLASH02: Interventions for Relief of Menopausal Symptoms: A 3-by-2 Factorial Design Examining Yoga, Exercise, and Omega-3 Supplementation

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.

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

- 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

- 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Frequency and bother of hot flashes measured by self-report diaries.

Outcome Time Frame:

12 weeks

Safety Issue:


Principal Investigator

Andrea Z. LaCroix, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center


United States: Federal Government

Study ID:




Start Date:

November 2010

Completion Date:

May 2012

Related Keywords:

  • Hot Flashes
  • Menopause
  • Vasomotor Symptoms
  • Hot Flashes
  • Menopause
  • Vasomotor symptoms
  • Yoga
  • Exercise
  • Omega-3
  • Fish oil
  • Hot Flashes



Indiana UniversityIndianapolis, Indiana  46202
Group Health Research InstituteSeattle, Washington  98101
Kaiser Division of ResearchOakland, California  94611