Breast Cancer Clinical Trial
Investigating Magnesium Glycinate in Structure/Function Role of Hot Flashes.
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.
Full 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.
Eligibility Criteria
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
Jacksonville Florida, 32224, United States
How clear is this clinincal trial information?
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.