Clinical trial NCT03564665: Investigating Magnesium Glycinate in Structure/Function Role of Hot Flashes.
Official title: A Randomized, Placebo Controlled, Single Blinded Trial of 400mg of Magnesium Glycinate BID Investigating the Body's Structure/Function Role of Hot Flashes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hot Flashes
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-06-21
Enrollment: 40
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Placebo Controlled, Single Blinded
Primary purpose: TREATMENT

Brief summary: The goal of this study is to further evaluate the effect of magnesium on the symptoms of menopause, specifically vasomotor symptoms (VMS) in breast cancer patients and/or women at an elevated risk of breast cancer.

Detailed description: Hot flashes are one of the most common symptoms that are experienced in women during perimenopause, menopause, and as a result of treatment of cancer such as breast cancer. Hot flashes, also known as vasomotor symptoms (VMS) may decrease a woman's quality of life due to discomfort, disruption of daily life, interruption of sleep, and worsening of depression. Previously, estrogen-based therapy was the primary treatment choice for VMS. However, in recent years, this has been considered less favorable due to the increased risk of breast cancer associated with estrogen-based therapy.

While medications such as certain antidepressants, gabapentin and clonidine are available as non-hormonal treatment options, they appear to be less effective in comparison to estrogen therapy with reported adverse effects.

Magnesium supplementation has been found to have very promising results in alleviating VMS in patients with a history of breast cancer. The goal of this study is to further investigate the effects of administering magnesium supplementation in reducing the effects of hot flashes in this targeted population. Our aim is to create a controlled trial using different dosages of magnesium glycinate in the management of hot flashes. Participants will be asked to complete surveys for data collection and analysis.

Eligibility criteria: Inclusion Criteria:

* Age: 25-85 years.
* Women with a history of invasive breast cancer, DCIS, or LCIS
* Creatine labs drawn within 90 days as part of Standard of Care.
* Bothersome hot flashes (defined by their occurrence of two or more hot flashes a day and/or of sufficient severity to prompt the patient to seek therapeutic intervention).
* Presence of hot flashes for \>30 days prior to study entry.
* Ability to complete questionnaire(s) by themselves or with assistance.
* Ability to provide informed written consent.
* Life expectancy ≥6 months.
* Willing to work with the enrolling institution for follow-up (during the Active Monitoring Phase of the study).
* ECOG Performance Status (PS) = 0, 1.

Exclusion Criteria:

* Pregnancy (Assessed on Intake Questionnaire. Positive Answer exclusionary)
* Any of the following current (≤4 weeks prior) or planned therapies:
* Antineoplastic chemotherapy (anti-HER2 agents allowed)
* Androgens
* Estrogens (any delivery route)
* Progestogens
* Tamoxifen, raloxifene and aromatase inhibitors are allowed, but patient must have been on a constant dose for at least 28 days and must not be expected to stop the medication during the study period
* SSRIs/SNRIs
* Gabapentin
* Clonidine
* Oxybutinin
* Stage IV or V renal disease or GFR\<30 in the last 90 days

Primary outcomes:
measure: Percent change in hot flash frequency
timeFrame: 8 weeks.
Secondary outcomes:
measure: Average change in hot flash frequency from baseline to week 8
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Dawn M Mussallem
role: PRINCIPAL_INVESTIGATOR
References: