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

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.

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