MPOWER: A Pilot Trial Among Men With Prostate Cancer: Optimizing Wellness by Enhanced Relief From Hot Flashes With Acupuncture
概览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Study feasibility - patient enrollment
概览
简要总结
Prostate cancer is the most common cancer among men in the United States. Many men with prostate cancer are treated with hormone therapy, also called androgen deprivation therapy (ADT). While this treatment is effective, it often causes bothersome side effects such as hot flashes, poor sleep, fatigue, and other physical and emotional symptoms. There is currently no standard treatment to help manage these side effects in men. Acupuncture is a non-drug treatment that has been shown to help reduce hot flashes and related symptoms in women receiving hormone therapy for breast cancer. However, much less is known about whether acupuncture is helpful for men receiving hormone therapy for prostate cancer. This study will test whether an acupuncture program, combined with usual lifestyle education, is feasible and acceptable for men undergoing ADT. The study will also explore whether acupuncture may help reduce hot flashes and improve related symptoms. A total of 24 men with prostate cancer receiving ADT will be randomly assigned to one of two groups: one group will begin acupuncture right away, and the other group will begin acupuncture after a delay, with regular check-ins during the waiting period. All participants will receive standard lifestyle education. Participants will be followed for about five months and will be asked to complete daily hot flash diaries, questionnaires about their symptoms and quality of life, and wear a Fitbit to track sleep. The results of this pilot study will help determine whether a larger study should be conducted to better understand the role of acupuncture in managing hormone therapy side effects in men with prostate cancer.
详细描述
This study is a pilot feasibility randomized controlled trial designed to evaluate the acceptability, feasibility, and delivery of an acupuncture intervention for men with prostate cancer receiving androgen deprivation therapy (ADT). A total of 24 participants will be enrolled and randomized in a 1:1 ratio to either an intervention arm with immediate acupuncture (IA) or a wait-list attention control arm with delayed acupuncture (DA), resulting in 12 participants per group. Randomization will be conducted using a simple randomization scheme.
Participants will be followed for a total of 22 weeks. Those assigned to the IA arm will receive a standardized acupuncture protocol consisting of weekly 30-minute manual acupuncture sessions for 10 weeks, administered by a certified acupuncturist with expertise in oncology care. In addition to acupuncture, participants in the IA arm will receive lifestyle education consistent with usual clinical practice. Following completion of the 10-week acupuncture period, participants in the IA arm will enter a 12-week follow-up phase without acupuncture treatment.
Participants assigned to the DA arm will receive lifestyle education per usual care during the initial 10-week period without acupuncture, along with scheduled check-ins with study staff to control for attention. At week 12, participants in the DA arm will begin the same standardized acupuncture protocol as the IA arm, consisting of weekly 30-minute sessions for 10 weeks. This design allows all participants to receive the acupuncture intervention while enabling comparison of feasibility and acceptability between immediate and delayed initiation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •At least 18 years of age
- •Histologically or cytologically confirmed adenocarcinoma of prostate of any stage I-IV
- •Undergoing androgen deprivation therapy (ADT) and/or androgen receptor pathway inhibitors
- •Experiencing moderate to severe daily interference from hot flashes, as indicated by the Hot Flash Related Daily Interference Scale (score≥4)
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- •Able to read, understand, and provide written informed consent
排除标准
- •Severe or uncontrolled concurrent disease, infection or co-morbidity that, in the opinion of the Investigator, would make the patient inappropriate for enrollment
- •Known hypersensitivity to the acupuncture needles
- •Any condition that in the opinion of the Investigator would impair the patients' ability to comply with the study procedures
- •Unable to comply with study requirements
- •Use of acupuncture for hot flashes within 6 months prior to enrollment
研究组 & 干预措施
Immediate Start Acupuncture
Participants randomized to the immediate start acupuncture (IA) arm will receive a 10-week standard acupuncture protocol, consisting of weekly 30-minute sessions, in addition to lifestyle education per usual care. Acupuncture will be delivered by a certified acupuncturist with expertise in oncology care. Following completion of the 10-week acupuncture period, participants will enter a 12-week follow-up phase during which no acupuncture treatments will be provided.
干预措施: Acupuncture (Other)
Delayed Start Acupuncture
Participants randomized to the delayed start acupuncture (DA) arm will receive lifestyle education per usual care without acupuncture during the initial 10-week comparison period. Beginning at week 12, participants will initiate the same 10-week standard acupuncture protocol, consisting of weekly 30-minute sessions delivered by a certified acupuncturist with expertise in oncology care.
干预措施: Lifestyle Management (Behavioral)
结局指标
主要结局
Study feasibility - patient enrollment
时间窗: 12 months
Study feasibility will be measured by patient enrollment rates, defined as the proportion of eligible patients approached about the study who consent to participate.
Study feasibility - Patient intervention engagement
时间窗: 18 months
Study feasibility will be measured by patient intervention engagement, defined as the proportion of enrolled patient subjects who attend at least 6 of 10 scheduled acupuncture visits.
次要结局
- Intervention acceptability - quantitative(11, 17, and 22 weeks)
- Intervention acceptability - qualitative(22 weeks)
- Hot Flash Severity Score(Baseline, 11, 17, and 22 weeks)