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

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Jacksonville, Florida: 18-000948
    NCT ID: NCT03564665
    Sponsor Protocol Number: 18-000948

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Age: 25-85 years.
  • Women with a history of invasive breast cancer, DCIS, or LCIS, or are at high risk for developing breast cancer
  • 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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Dawn Mussallem, D.O.

Open for enrollment

Contact information:

Amanda Arnold

(904)953-3652

Arnold.Amanda1@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions