Investigating Magnesium Glycinate in Structure/Function Role of Hot Flashes.
Overview
Tab Title Description
Study type
InterventionalDescribes 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.
Study IDs
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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Age: 25-85 years old.
- 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;
- Systemic estrogens (topical vaginal estrogen OK);
- 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 the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Dawn Mussallem, D.O. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available