The Use of Pycnogenol® to Alleviate Menopausal Symptoms Induced or Increased by Breast and Gynecological Cancer Treatments
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 6
- 主要终点
- Menopause Rating Scale (MRS)
研究概览
简要总结
This is a pilot study to test whether PYC can improve climacteric symptoms for women who have experienced either surgically or medically induced menopause as part of their treatment for breast or gynecologic cancers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patient currently is undergoing treatment for cancer
- •Patient has menopausal symptoms induced either by surgical or medical (patient on tamoxifen or aromatase inhibitor) interventions for cancer
- •> 18 years of age
- •Willing to travel to a Legacy Health facility if necessary
- •Agree to attend study visits outside of standard of care visits, if needed
- •Willing to stop other supplements or medications that are aimed at treating menopausal symptoms at least 7 days before beginning study treatment
- •Willing to engage in pre/post testing and survey/phone calls
排除标准
- •Patient is currently undergoing chemotherapy treatment
- •< 18 years of age
- •Unable to comply with protocol
- •Unable to provide written informed consent
- •Investigator does not believe study participation is in the best interest of the patient
- •Patient had concurrent menopausal symptoms prior to the start of cancer treatment
- •Menopausal symptoms are unrelated to surgical or medical treatment of breast or gynecologic cancers
结局指标
主要结局
Menopause Rating Scale (MRS)
时间窗: The MRS will be administered at baseline, after 4 weeks, after 8 weeks, 2 week follow-up (10 weeks), and 1 month follow up (12 weeks) with the intention of calculating DFB score at each time point.
The MRS will be used to evaluate the efficacy of PYC in decreasing menopausal symptoms as compared to placebo. The difference-from-baseline (DFB) score will be calculated by taking the composite MRS score at 10 weeks and 12 weeks compared to the MRS score at baseline to determine whether or not PYC reduces symptoms, if the effects last beyond actively taking PYC, and if so, how long. The purpose of multiple time point assessments is two-fold: first, some patients will be taking placebo and some will be taking active drug in the first month, and vice versa during the second month. Therefore, an assessment needs to be done at each timepoint, weeks 4 and 8. Second, we are interested in understanding how long the symptoms management may last without actively taking drug, which accounts for the 10 week and 12 week timepoints.
次要结局
未报告次要终点
研究者
Reza Antoszewska
Legacy Health Foundation
Legacy Health System