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

Launched by MAYO CLINIC · Jun 11, 2018

Keywords

ClinConnect Summary

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 med...

Gender

FEMALE

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