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

NCT ID: NCT03564665

Last Updated: 2021-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-24
• Study Completion Date: 2021-04-10

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.

Detailed Description

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.

Conditions

Hot Flashes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

400mg Magnesium Glycinate BID 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.

Group Type: EXPERIMENTAL

400mg Magnesium Glycinate BID

Intervention Type: DIETARY_SUPPLEMENT

400mg Magnesium Glycinate BID for 8 weeks.

Control Arm

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo BID for 8 weeks.

Interventions

400mg Magnesium Glycinate BID

400mg Magnesium Glycinate BID for 8 weeks.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo BID for 8 weeks.

Intervention Type: OTHER

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Dawn M. Mussallem, D.O.

Dawn M. Mussallem, D.O.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dawn M Mussallem

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Florida

Jacksonville, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

18-000948

Identifier Type: -

Identifier Source: org_study_id