Black Cohosh (Actaea Racemosa) for Hot Flashes in Prostate Cancer Patients on Androgen Deprivation Therapy: A Randomized, Placebo-Controlled, Double-Blind Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 主要终点
- Frequency of hot flashes as calculated from self reported questionnaire
研究概览
简要总结
This is a randomized, placebo-controlled crossover study. Participants will be actively participating in the study for 6 months, and enrolled in the study for up to 1 year. During the first phase of the study, the participants will be randomized into either the placebo group or treatment group for 8 weeks following 1 week of baseline data collection (no treatment). Following this first phase, a no-treatment washout period of at least 3 weeks will be implemented for all participants. After the washout period, the randomized groups will switch from treatment to placebo group, or placebo to treatment group for an additional 8 week period. Hot flash frequency and severity will be documented using a daily hot flash diary and calculated using the Hot Flash Score questionnaire. The impact on quality of life will be documented by weekly Hot Flash Related Daily Interference Scale (HFRDIS) questionnaires.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Able to understand English or be wiling to use a trained interpreter
- •Diagnosis of prostate cancer
- •Receiving either Leuprolide or Degarelix,for prostate cancer treatment
- •Currently experiencing a minimum of 3 self-reported hot flashes within a 24 hour period
- •Eastern Cooperative Oncology Group (ECOG) performance status score < 2
- •Life expectancy >3 months.
- •No grade 3 or higher toxicity from prior cancer therapies unless judged by the principal investigator to be clinically irrelevant to study procedures
- •At least four (4) weeks following prior major surgery
- •Serum testosterone concentration below castrate level (< 30 ng/dL) at time of recruitment
- •Willing to provide written informed consent for participation in the study
排除标准
- •Concurrent severe illness effecting ECOG performance status or life expectancy as determined by the principal investigator
- •Hormone refractory patients. Patients taking Enzalutamide or Abiraterone.
- •Active infection
- •Psychiatric illness or social situation that would limit safety and compliance with study requirements
- •Currently taking any pharmaceutical medications that have potential interactions with black cohosh as determined by the principal investigator
- •Currently taking any supplements that have potential interactions with black cohosh as determined by the principal investigator
- •Currently receiving any treatment for hot flashes or planning to initiate any treatment for hot flashes other than with study supplementation
- •ALT, AST, or Bilirubin > 2 times their normal laboratory values in the past 3 months
- •Inability to complete the informed consent process or adhere to the protocol treatment plan.
研究组 & 干预措施
Black Cohosh Therapy
Black Cohosh will be provided in 250mg capsules. Subjects will take 2 capsules by mouth daily for a total daily dose of 500 mg. Subject's will remain on this study arm for 8 weeks.
干预措施: Black Cohosh (Drug)
Placebo
Subjects will take 2 capsules, identical to the Black Cohosh capsules, by mouth each. Subject's will remain on this study arm for 8 weeks.
干预措施: Placebo (Other)
结局指标
主要结局
Frequency of hot flashes as calculated from self reported questionnaire
时间窗: Daily assessments throughout the study (assessed for up to 16 weeks)
Subjects will record the number and timing of their on the Hot Flash Related Daily Interference (HFRDIS) questionnaire each week during the study.
次要结局
- Severity of hot flashes as calculated from self reported questionnaire(Daily assessments throughout the study (assessed for up to 16 weeks))
- Quality of life as recorded from self reported questionnaire(Daily assessments throughout the study (assessed for for up to 16 weeks))
- Measurement of serum testosterone(From the beginning of treatment to the end of the 8-week treatment phase (up to 16 weeks due to cross-over of study arms))
- Measurement of serum aspartate aminotransferase (AST)(From the beginning of treatment to the end of the 8-week treatment phase (up to 16 weeks due to cross-over of study arms))
- Measurement of serum alanine aminotransferase (ALT)(From the beginning of treatment to the end of the 8-week treatment phase (up to 16 weeks due to cross-over of study arms))
- Measurement of serum bilirubin(From the beginning of treatment to the end of the 8-week treatment phase (up to 16 weeks due to cross-over of study arms))
- Measurement of serum Prostate Specific Antigen (PSA)(From the beginning of treatment to the end of the 8-week treatment phase (up to 16 weeks due to cross-over of study arms))
研究者
Evan Pisick
Medical Oncologist
Midwestern Regional Medical Center