Investigating Magnesium Glycinate in Structure/Function Role of Hot Flashes.
A Randomized, Placebo Controlled, Single Blinded Trial of 400mg of Magnesium Glycinate BID Investigating the Body's Structure/Function Role of Hot Flashes.
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2018
CompletedFirst Posted
Study publicly available on registry
June 21, 2018
CompletedStudy Start
First participant enrolled
July 24, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 10, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 10, 2021
CompletedApril 12, 2021
April 1, 2021
2.7 years
June 11, 2018
April 9, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Percent change in hot flash frequency
The primary endpoint of this study will be the percent change in hot flash frequency from baseline to week 8. A two independent sample z-test (assuming equal variances) or a Wilcoxon rank-sum test will be used for the analysis of this endpoint.
8 weeks.
Secondary Outcomes (1)
Average change in hot flash frequency from baseline to week 8
8 weeks
Study Arms (2)
400mg Magnesium Glycinate BID Arm
EXPERIMENTALPrescription 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.
Control Arm
PLACEBO COMPARATORPrescription 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.
Interventions
400mg Magnesium Glycinate BID for 8 weeks.
Eligibility Criteria
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:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Florida
Jacksonville, Florida, 32224, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dawn M Mussallem
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Placebo
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dawn M. Mussallem, D.O.
Study Record Dates
First Submitted
June 11, 2018
First Posted
June 21, 2018
Study Start
July 24, 2018
Primary Completion
April 10, 2021
Study Completion
April 10, 2021
Last Updated
April 12, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share