Investigating Magnesium Glycinate in Structure/Function Role of Hot Flashes.
Hot Flashes
About this trial
This is an interventional treatment trial for Hot Flashes
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
Sites / Locations
- Mayo Clinic in Florida
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
400mg Magnesium Glycinate BID Arm
Control Arm
Prescription for an 8 week supply (+/- 4 days) of Magnesium Glycinate will be sent to the pharmacy for patient pick up. Study Coordinator will then dispense study diaries (Supplementation Diary and Hot Flash Diary) with instructions on how to complete for the eight week study duration. Study Coordinator will discuss upcoming phone calls on Weeks 2-8 to complete the MDASI by phone and the best times to do so with the patient. Coordinator will schedule a return visit with the Patient approximately 9 weeks after the start of the study for follow-up. At follow-up, Coordinator will retrieve Patient Diaries (Hot Flash Diary and Medication Diary), perform supplement reconciliation, and exit Patient from the study.
Prescription for an 8 week supply (+/- 4 days) of placebo will be sent to the pharmacy for patient pick up. Study Coordinator will then dispense study diaries (Supplementation Diary and Hot Flash Diary) with instructions on how to complete for the eight week study duration. Study Coordinator will discuss upcoming phone calls on Weeks 2-8 to complete the MDASI by phone and the best times to do so with the patient. Coordinator will schedule a return visit with the Patient approximately 9 weeks after the start of the study for follow-up. At follow-up, Coordinator will retrieve Patient Diaries (Hot Flash Diary and Medication Diary), perform supplement reconciliation, and exit Patient from the study.