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Completed

NCT Number: NCT03564665

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

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.

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Key information

Conditions

Hot Flashes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

400mg Magnesium Glycinate BID

Dietary Supplement

400mg Magnesium Glycinate BID for 8 weeks.

Placebo

Other

Placebo BID for 8 weeks.

Primary outcomes

  1. Percent change in hot flash frequency

    Time frame: 8 weeks.

    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.

Secondary outcomes

  1. Average change in hot flash frequency from baseline to week 8

    Time frame: 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jun 21, 2018
Registry last updated
Apr 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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