Role of Folic Acid in the Management of Adjuvant Endocrine Therapy-Induced Hot Flashes in Breast Cancer Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Reduction in Hot Flash Frequency and Severity
研究概览
简要总结
The study aims to assess the efficacy of folic acid supplementation at two doses (1 mg/day and 5 mg/day) in the management of hot flashes associated with adjuvant endocrine therapy among premenopausal breast cancer patients.
详细描述
Folic acid is one of the B vitamins that when absorbed into its active form is converted to tetrahydrofolate. Folate is an essential cofactor for the biosynthesis of norepinephrine and serotonin. Studies have also noted that folate, with a mechanism like hormone replacement therapy (HRT), can improve hot flashes by interfering with monoamine neurotransmitters called norepinephrine and serotonin .The purpose of the current study is to investigate the role of folic acid administration at two different doses (1 mg/day and 5 mg/day) in the management of hot flashes associated with adjuvant endocrine therapy in patients with breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females older than 18 years
- •Diagnosed with confirmed breast cancer and currently treated with an adjuvant endocrine
- •Experiencing bothersome hot flashes at least 14 times/week
- •Taking the treatment within 6 months to two years.
- •Able to read and write to complete the study questionnaires and hot-flash diary.
排除标准
- •Known hypersensitivity to folic acid
- •Patients who have been treated with selective serotonin reuptake inhibitors (SSRIs) within the past 30 days.
- •Metastatic breast cancer
- •Renal impairment (Serum creatinine > 2 mg/dl)
- •Significant liver disease: liver enzymes 2 folds the upper normal limit
- •Taking other medication for hot flashes
- •Medications inducing hot flashes such as (Clomiphene, Opioids, Nifedipine, Prednisone)
研究组 & 干预措施
Intervention
Folic acid 1mg oral tablet
干预措施: Folic Acid 1 Mg Oral Tablet (Drug)
Treatment
Folic acid 5mg oral tablet
干预措施: Folic Acid 5 Mg Oral Tablet (Drug)
Control
The patient will not be administered with any drug/placebo
结局指标
主要结局
Reduction in Hot Flash Frequency and Severity
时间窗: 3 months
It is measured using the daily hot flash diary, which tracks the number and intensity of hot flashes over the study period.
次要结局
- Improvement in Quality of Life(3 months)
- Correlation with Folic Acid Blood Levels(3 months)
研究者
Fatma Abdalkarim
Assistant Lecturer - Pharmacy Practice & Clinical Pharmacy
Future University in Egypt