A Randomized, Placebo Controlled, Single Blinded Trial of 400mg of Magnesium Glycinate BID Investigating the Body's Structure/Function Role of Hot Flashes.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Percent change in hot flash frequency
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Placebo
入排标准
- 年龄范围
- 25 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Percent change in hot flash frequency
时间窗: 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.
次要结局
- Average change in hot flash frequency from baseline to week 8(8 weeks)
研究者
Dawn M. Mussallem, D.O.
Dawn M. Mussallem, D.O.
Mayo Clinic