Acupuncture Versus Sham Acupuncture or Usual Care for Antiandrogen-Induced Hot fLashes in Prostate Cancer (AVAIL): a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Weekly mean hot flash symptom severity score (HFSSS)
研究概览
简要总结
Hot flashes are a common and debilitating symptom among prostate cancer patients undergoing androgen deprivation therapy (ADT). Strong evidence from multiple rigorously designed studies indicated that venlafaxine provides partial relief, but the tolerability is poor when the dose is not tapered. Hence, an alternative therapy is needed. Previous studies reported that acupuncture may be helpful in the management of hot flashes. However, the insufficient randomized controlled trial limited the quality of evidence.
详细描述
The number of men surviving after being diagnosed with prostate cancer has increased rapidly. According to population-based cancer registry data, 10-year survival has tripled in the past 40 years in the UK. Androgen deprivation therapy (ADT) is a mainstay of prostate cancer treatment and has been shown in randomized controlled trials to improve overall survival when used with radiation for intermediate- and high-risk localized disease, as well as locally advanced and node-positive disease, and after surgery for the node-positive disease. Although ADT can improve survival, it can also cause significant morbidity and a decrement in quality of life. One of the most bothersome side effects is hot flashes. They are experienced as sudden and transient episodes of heat and sweating, with possible co-occurring palpitations and anxiety, usually persist long-term. The prevalence estimated that 44-80% of patients undergoing ADT report hot flashes and up to 27% report this as the most troublesome adverse effect. Although hot flashes are not fatal morbidity, it may interfere with adherence to lifesaving therapies or ablative therapies that are used to prevent or treat cancer.
Currently, most intervention studies for hot flashes have evaluated treatments in breast cancer patients or women who are postmenopausal. Venlafaxine, a selective serotonin reuptake inhibitor, appears to be effective and safe in both breast cancer women and prostate cancer men with hot flashes. It has been recommended for practice in men with strong evidence from multiple rigorously designed studies. However, some prostate cancer patients cannot take venlafaxine because of side effects such as nausea, headache, dry mouth, dizziness, insomnia, and constipation. Thus, an alternative therapy is needed. A systematic review identified six studies of acupuncture for hot flashes, of which none were randomized and placebo-controlled. Although acupuncture is a nonpharmacologic therapy and has been confirmed that could be helpful in the management of hot flashes among breast cancer survivors, there is no placebo acupuncture-controlled trials demonstrating its efficacy in men.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The principal investigator, study investigators, patients, study staff, and the statistician will be blinded to the treatment assignments among interventions. The acupuncturists cannot be blinded to verum acupuncture or the sham owing to the characteristics of acupuncture procedure. Patients allocated to both verum acupuncture and sham acupuncture groups will be asked to guess which type of acupuncture (verum acupuncture, sham acupuncture, or unclear) they had received after the end of last treatment.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •patients aging from 18 to 75 years diagnosed with prostate cancer undergoing ADT;
- •with an average of 3 or more hot flashes a day for at least 3 days before enrollment and no other clinically significant disease;
- •not receiving any medications for hot flashes nor did they have a previous history of acupuncture treatment.
排除标准
- •hormonal treatment other than GnRH analogue
- •daily treatment with psychotropic drugs
- •newly started or changed alternative medications with possible effects on flushes uncontrolled hypertension or metabolic disease
- •inability to move/lie on the side, and treatment with anticoagulants or pacemaker.
结局指标
主要结局
Weekly mean hot flash symptom severity score (HFSSS)
时间窗: Baseline to week 6
The HFSSS is defined as the product of "hot frequency" and "hot severity". The severity of hot flashes is assessed based on the duration of hot flashes and physical and emotional symptoms; it is scored as mild, moderate, severe, and very severe (range 1-4, from mild to very severe).
次要结局
- Response rate of HFSSS(Baseline, week 6, and week 14)
- The Zung Self-Rating Depression Scale (SDS)(Baseline, week 6, and week 14)
- International Index of Erectile Function (IIEF-5)(Baseline, week 6, and week 14)
- Weekly mean hot flash symptom severity score (HFSSS)(Baseline to week 14)
- Functional Assessment of Cancer Therapy-Prostate (FACT-P)(Baseline, week 6, and week 14)
- The Zung Self-Rating Anxiety Scale (SAS)(Baseline, week 6, and week 14)
研究者
Jiani Wu
Dr.
Guang'anmen Hospital of China Academy of Chinese Medical Sciences