Clinical trial NCT01488864: Applied Relaxation for Vasomotor Symptoms
Official title: Applied Relaxation for Vasomotor Symptoms in Postmenopausal Women - a Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Menopause
Hot Flashes
Keywords: Hot flashes
Vasomotor symptoms
Menopause
Applied Relaxation
Health Related Quality of Life
Salivary cortisol
Lead sponsor: Ostergotland County Council, Sweden
Sponsor class: OTHER
First posted: 2011-12-08
Enrollment: 60
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objectives of this study are to compare frequency and severity of moderate to severe vasomotor symptoms in postmenopausal women treated with applied relaxation (AR) with an untreated control-group (CG) and to investigate if Health Related Quality of Life improve in the AR-group compared to an untreated CG.To study if salivary cortisol excretion would change within the AR treated group compared with the control group.

Detailed description: Approximately 70% of women in Europe and North America experience hot flashes and night sweats during the climacteric period. Many women abstain from hormonal therapy because of side effects or contraindications such as breast cancer or thrombosis.

Different alternative therapies for alleviation of hot flashes are described in the literature. Both pharmacological treatments, different types of natural remedies, acupuncture, life-style changes and mind-body therapies are suggested as promising therapies. Applied relaxation (AR) is a technique influenced on cognitive behavioral therapy (CBT) using coping mechanism and conditioning. Previous study with healthy postmenopausal women showed promising results on hot flash frequency with an average decrease of more than 70 % with persisting effect three months after therapy and also HRQoL significantly increased probably due to better sleep and diminished vasomotor symptoms. But the method must be further investigated before strong evidence-based conclusion can be drawn.

Cortisol is a potent stress hormone regulated by the hypothalamic-pituitary axis. The factors underlying how alternative treatment works and the mechanism underlying improvements in symptoms are not fully understood.

Eligibility criteria: Inclusion Criteria:

* postmenopausal women (at least 12 months since last menstrual bleeding occurred or in previously hysterectomised women a serum follicle-stimulating hormone (S-FSH) defined as postmenopausal level according to references at the local laboratory)
* More or equal to 7 moderate to severe hot flashes or more or equal at 50 hot flashes per week according to a two-week screening diary
* ability to understand and speak Swedish
* freely given informed consent

Exclusion Criteria:

* unstable thyroid or other metabolic disease
* treatment with hormone therapy (HT) or other complementary- or alternative treatments treatment for menopausal-related symptoms
* treatment with psychopharmacological drugs and/or sedatives d-un-treated psychiatric disease
* frequently exercising women (≥ 2h high-intensity activities/week)

Primary outcomes:
measure: Hot flashes average number and severity
timeFrame: Baseline to 12 week after "start of treatment"
Secondary outcomes:
measure: Hot flashes
timeFrame: Baseline to 3 months after "end of treatment"
measure: Hot flashes reduction of hot flashes
timeFrame: Baseline to 3 months after "end of treatment"
measure: Health Related Quality of Life
timeFrame: Baseline to 3 months "end of treatment"
measure: Adverse Events
timeFrame: Baseline to 3 months "end of treatment"
measure: Salivary cortisol
timeFrame: Baseline to 3 months after "end-of-treatment"
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: University Hospital, Dept of Obstetrics and Gynecology
Study officials:
affiliation: Ostergotland CC, University Hospital Dept. of Obstetrics and Gynecology, 582 85 Linköping, Sweden
name: Elizabeth Nedstrand, Md, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Nedstrand E, Wijma K, Wyon Y, Hammar M. Applied relaxation and oral estradiol treatment of vasomotor symptoms in postmenopausal women. Maturitas. 2005 Jun 16;51(2):154-62. doi: 10.1016/j.maturitas.2004.05.017.
citation: Nedstrand E, Wijma K, Wyon Y, Hammar M. Vasomotor symptoms decrease in women with breast cancer randomized to treatment with applied relaxation or electro-acupuncture: a preliminary study. Climacteric. 2005 Sep;8(3):243-50. doi: 10.1080/13697130500118050.
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