A Randomized Placebo-controlled Trial of Ashwagandha (Withania Somnifera) for Cognitive Dysfunction Associated With Cancer Chemotherapy.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- FACT-Cog PCI
研究概览
简要总结
This is a 1:1 randomized double blinded placebo controlled trial. • To determine if ashwagandha can improve cognitive dysfunction when compared with placebo in patients undergoing chemotherapy for cancer.
详细描述
Patients are eligible if they are currently undergoing chemotherapy or treatment with chemotherapy in the past year and state that they notice thinking or memory problems. Patients will be given FACT-Cog PCI (Version 3). Patients that score less than 63, a score that reflects moderate to severe cognitive problems, are confirmed eligible. Subjects will be randomized 1:1 in blocks of 4.
Thyroid hormone testing will be conducted at baseline and at the end of week 6 for patients with a history of thyroid disease.
Patients will receive ashwagandha 350 mg po BID or placebo. The investigators and participants will be blinded to group assignment.
Endpoint testing including the FACT-Cog PCI and total score, Hopkins verbal learning test, trail making test (abstraction and executive function), and Mini Mental Status Exam (MMSE) will be administered at baseline and after 9 weeks of treatment. Six months after stopping the study, patients will receive a link to a REDCap database to complete the FACT-Cog and state whether they used ashwagandha once they completed the study.
Active study participation will be for 9 weeks.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years and older
- •English speaking
- •Currently undergoing chemotherapy or treatment with chemotherapy in the past year
- •Self-reported memory loss, attention, visual-spatial functioning, reasoning, or information processing or cognitive changes in the first 2 cycles of chemotherapy and score < 63 on the FACT-Cog PCI
- •Able to follow instructions for testing and comply with testing
- •Able to swallow pills
排除标准
- •Undergoing treatment for any hormone dependent cancer
- •Planned surgical treatment
- •History of pre-existing dementia, untreated depression, psychiatric disorder, prior brain radiation or brain injury
- •History of hypotension
- •Active autoimmune disease
- •Brain metastasis
- •Taking any drugs daily that would alter cognition
- •Concurrent use of benzodiazepenes or other sedatives
- •Concurrent use of supplements that can cause sedation such as 5-HTP, calamus, California poppy, hops, Jamaican dogwood, kava, St.John's Wort, skullcap, valerian, yerba mansa
- •Currently taking hypoglycemic medications
- •History of substance abuse
- •Current or recent diagnosis of stomach ulcer or gastritis
研究组 & 干预措施
ashwagandha
Ashwagandha
干预措施: Ashwagandha (Drug)
placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
FACT-Cog PCI
时间窗: 9 weeks
The Functional Assessment of Cancer Therapy - Cognition (FACT-Cog) is a 37-item questionnaire designed to assess cognitive complaints in patients with cancer. The Perceived Cognitive Impairment (PCI) subscale consists of 20 items designed to measure perceived impairment in quality of life. Scores range from 0-72 where higher scores indicate less impairment and better quality of life.
次要结局
未报告次要终点
研究者
Deepti Behl
Principal Investigator
Sutter Health