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

Hot Flashes Clinical Trial

Official title:

A Randomized, Placebo Controlled, Single Blinded Trial of 400mg of Magnesium Glycinate BID Investigating the Body's Structure/Function Role of Hot Flashes.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03564665
• Other study ID #: 18-000948
• Status: Completed
• Phase: N/A
• Start date: July 24, 2018
• Est. completion date: April 10, 2021

Study information

• Verified date: April 2021
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 10, 2021
• Est. primary completion date: April 10, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Hot Flashes

Intervention

Dietary Supplement:
• 400mg Magnesium Glycinate BID
400mg Magnesium Glycinate BID for 8 weeks.

Other:
• Placebo
Placebo BID for 8 weeks.

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Average change in hot flash frequency from baseline to week 8	The secondary analysis, we will also look at the average change in hot flash frequency from baseline to week 8 and compare these means using a two-sample t-test or a Wilcoxon rank-sum test. Adverse events (as captured using the NCI CTCAE version 4) will be compared between the two investigational arms using summary statistics. Frequencies of adverse events will be compared using chi-square tests or Fisher's exact tests. Change in QOL (as measured by the MDASI) from baseline to week 8 will be compared for each question between the investigational arms using two sample t-tests or Wilcoxon rank sum tests.	8 weeks