Investigating Magnesium Glycinate in Structure/Function Role of Hot Flashes.

Completed · Not applicable · Has a placebo group

Conditions studied: Hot Flashes

In brief

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.

Key facts

Study ID

NCT03564665

Run by

Mayo Clinic

People needed

40

Starts

2018-07-24

Expected to finish

2021-04-10

Last updated by the study team

2021-04-12

Who can join

Age: 25 and older, up to 85. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Mayo Clinic in Florida — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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