Clinical trial NCT01281332: Mechanical Device for the Relief of Hot Flashes
Official title: Evaluation of a Novel Mechanical Device for Relief of Menopausal Vasomotor Symptoms.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hot Flashes
Keywords: menopause
hot flash
quality of life
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: Alexander Medical Inc.
First posted: 2011-01-21
Enrollment: 40
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypothesis: A mechanical device when applied to the back of the neck at the onset of a menopausal hot flash will attenuate the severity and duration of symptoms providing women with a reassuring non-hormonal intervention to improve quality of life in the menopausal transition. This pilot study will evaluate the effectiveness of this unit.

The mechanism of action of the device will not be revealed in advance.

Detailed description: This is a pilot study to test logistics and gather information for planning the definite trial. We will randomly allocate 40 subjects to receive either the active Menopod device (n=20) or a sham device with the mechanism disabled (n=20).

We will recruit menopausal women with moderate to severe hot flashes (as defined by FDA standards this means a minimum of 7 per day).

The two primary outcome parameters are the hot flash score which is the product of frequency x intensity (Sloan 2001), and the average duration (in minutes) of hot flash episodes over the course of one day. These outcomes will be self-recorded by subjects in a diary designed by our research team on five separate days throughout the course of the study, once during the evaluation phase and once per week over the four week treatment phase. The two summary measures will be the changes from baseline to the last record collected for hot flash scores and average durations. Delta values (assessment phase minus fourth treatment period) will be compared between the two treatment groups (active versus sham device) using t tests (IBM SPSS Statistics version 21).

Eligibility criteria: Inclusion Criteria:

* Age range: 40 to 65 years
* Healthy postmenopausal woman
* natural or surgical menopause
* FSH \> 30 IU/L
* Amenorrhea \> 6 months prior to study
* Minimum of 7 moderate hot flashes per day documented in diary during evaluation phase

Exclusion Criteria:

* Any therapy for hot flashes prior to or during study
* Obesity: BMI \> 35
* Alcohol abuse
* Drug abuse
* Unable to use device as per protocol
* Unable to complete required documentation
* Serious medical condition:
* coronary heart disease
* stroke
* chronic renal or hepatic disease
* diabetes
* depression or other psychiatric illness
* cancer

Primary outcomes:
measure: Hot flash score and duration
timeFrame: Change from baseline to end of study (week 4).
Secondary outcomes:
measure: Quality of Life (QOL) and Anxiety
timeFrame: Change from baseline to end of study (week 4).
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
Study officials:
affiliation: Queen's University
name: Robert L. Reid, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sloan JA, Loprinzi CL, Novotny PJ, Barton DL, Lavasseur BI, Windschitl H. Methodologic lessons learned from hot flash studies. J Clin Oncol. 2001 Dec 1;19(23):4280-90. doi: 10.1200/JCO.2001.19.23.4280.
citation: Carpenter JS. The Hot Flash Related Daily Interference Scale: a tool for assessing the impact of hot flashes on quality of life following breast cancer. J Pain Symptom Manage. 2001 Dec;22(6):979-89. doi: 10.1016/s0885-3924(01)00353-0.
citation: Zung WW. A rating instrument for anxiety disorders. Psychosomatics. 1971 Nov-Dec;12(6):371-9. doi: 10.1016/S0033-3182(71)71479-0. No abstract available.