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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03564665
Recruitment Status : Active, not recruiting
First Posted : June 21, 2018
Last Update Posted : May 28, 2020
Sponsor:
Information provided by (Responsible Party):
Dawn M. Mussallem, D.O., Mayo Clinic

Tracking Information
First Submitted Date  ICMJE June 11, 2018
First Posted Date  ICMJE June 21, 2018
Last Update Posted Date May 28, 2020
Actual Study Start Date  ICMJE July 24, 2018
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2018)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigating Magnesium Glycinate in Structure/Function Role of Hot Flashes.
Official Title  ICMJE A Randomized, Placebo Controlled, Single Blinded Trial of 400mg of Magnesium Glycinate BID Investigating the Body's Structure/Function Role of Hot Flashes.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized, Placebo Controlled, Single Blinded
Masking: Single (Participant)
Masking Description:
Placebo
Primary Purpose: Treatment
Condition  ICMJE Hot Flashes
Intervention  ICMJE
  • Dietary Supplement: 400mg Magnesium Glycinate BID
    400mg Magnesium Glycinate BID for 8 weeks.
  • Other: Placebo
    Placebo BID for 8 weeks.
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Dietary Supplement: 400mg Magnesium Glycinate BID
  • Placebo Comparator: 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.
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 11, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 25 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03564665
Other Study ID Numbers  ICMJE 18-000948
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dawn M. Mussallem, D.O., Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dawn M Mussallem Mayo Clinic
PRS Account Mayo Clinic
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP