Comparing Acupuncture vs. Sham Acupuncture for the Management of Hot Flashes in Prostate Cancer Patients Receiving Hormone Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in Hot Flash Score
研究概览
简要总结
This study is evaluating whether acupuncture may help reduce hot flashes in men receiving hormone therapy for prostate cancer. Hot flashes are a common side effect of androgen deprivation therapy (ADT) and may negatively affect sleep, mood, concentration, daily activities, and overall quality of life.
Participants enrolled in this study will receive acupuncture treatment over a defined treatment period. The study will assess changes in hot flash frequency, severity, and quality of life using patient questionnaires and symptom diaries. Participants will complete a daily hot flash diary during selected 7-day assessment periods and quality-of-life questionnaires during study visits.
The primary goal of this study is to determine whether acupuncture may improve hot flash symptoms and related quality of life in men undergoing treatment for prostate cancer.
详细描述
Hot flashes are a common and bothersome side effect experienced by men receiving androgen deprivation therapy (ADT) for prostate cancer. Symptoms may include sudden warmth, sweating, flushing, sleep disturbance, fatigue, mood changes, and reduced quality of life. Although medications such as antidepressants may help some patients, these treatments may also cause side effects and are not effective for all individuals. Acupuncture has been studied as a non-drug approach for management of hot flashes, but additional prospective studies are needed in men with prostate cancer receiving ADT.
This study is a prospective clinical study evaluating acupuncture for the management of ADT-related hot flashes in men with prostate cancer. Participants will undergo acupuncture treatment during the active treatment phase according to the study treatment schedule.
The study will evaluate changes in:
Hot flash frequency Hot flash severity Hot flash-related quality of life Interference of hot flashes with daily activities, sleep, mood, and social functioning
Patient-reported outcomes will be collected using standardized symptom assessments, including:
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
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with history of prostate cancer with currently receiving hormone therapy or had received hormone therapy in the past two years
- •Hormone therapies may include androgen deprivation therapy ( ADT; e.g., leuprolide, degarelix, or relugolix) or androgen signaling inhibitors (e.g., enzalutamide, apalutamide, or darolutamide) or adrenal steroid synthesis inhibitor (e.g., abiraterone acetate).
- •Patients may also receive additional treatments such as chemotherapy, radioligand therapy or target therapy in combination with hormone therapy.
- •Reports hot flashes at least twice per day. Patients may already be taking medications for hot flashes. There is no limit on the number of hot flash medications they can be using.
- •ECOG performance status =3 (see Appendix A).
- •Patients may participate in other therapeutic clinical trials for the treatment of prostate cancer. They will remain eligible as long as they meet the eligible criteria.
- •Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.
- •Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy.
- •Patients with a prior or concurrent malignancy are eligible for this trial.
- •Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.
排除标准
- •Patients can't travel for acupuncture
- •Patients with high bleeding tendency as determined by PI
研究组 & 干预措施
Sham Acupuncture
Participants receive acupuncture administered by a licensed and NCCAOM board certified acupuncturist at non-acupuncture points twice weekly for 6 weeks followed by a 4 week washout period before participants crossover to the real acupuncture arm.
干预措施: Sham Acupuncture (Device)
Real Acupuncture
Participants receive acupuncture administered by a licensed and NCCAOM board certified acupuncturist at predefined acupuncture points twice weekly for 6 weeks followed by a 4 week washout period before participants crossover to the sham acupuncture arm.
干预措施: Real Acupuncture (Device)
结局指标
主要结局
Change in Hot Flash Score
时间窗: Baseline and week 6
Weekly hot flash score will be calculated from a 7-day hot flash diary. Daily hot flash score is calculated as the number of hot flashes per day multiplied by the maximum severity score for that day. Weekly hot flash score is calculated as the sum of daily hot flash scores over 7 days. The primary outcome is the change in weekly hot flash score from baseline to Week 6.
次要结局
- Change in Hot Flash Related Daily Interference Scale (HFRDIS) Score(Baseline, Week 6, Week 16)
- Proportion of Participants Achieving ≥50% Reduction in Weekly Hot Flash Score(Week 6 and Week 16)
- Change in Mean Daily Hot Flash Frequency(Baseline, Week 6, Week 16)
研究者
Zin W Myint
Associate Professor
University of Kentucky