Clinical trial NCT05069467: Acupuncture Versus Sham Acupuncture or Usual Care for Antiandrogen-Induced Hot fLashes in Prostate Cancer (AVAIL)
Official title: Acupuncture Versus Sham Acupuncture or Usual Care for Antiandrogen-Induced Hot fLashes in Prostate Cancer (AVAIL): a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hot Flashes
Prostate Cancer
Acupuncture
Keywords: Prostate Cancer
Hot Flashes
Acupuncture
Randomized Controlled Trial
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: West China Hospital
name: Yantai Hospital of Traditional Chinese Medicine
name: Affiliated Hospital of Nanjing University of Chinese Medicine
name: Jiangsu Cancer Institute & Hospital
First posted: 2021-10-06
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomly 2:1:1 allocated to the verum acupuncture (n=60), sham acupuncture (n=30), or usual care (n=30) group.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Weekly mean hot flash symptom severity score (HFSSS)
timeFrame: Baseline to week 6
Secondary outcomes:
measure: Weekly mean hot flash symptom severity score (HFSSS)
timeFrame: Baseline to week 14
measure: Response rate of HFSSS
timeFrame: Baseline, week 6, and week 14
measure: Functional Assessment of Cancer Therapy-Prostate (FACT-P)
timeFrame: Baseline, week 6, and week 14
measure: International Index of Erectile Function (IIEF-5)
timeFrame: Baseline, week 6, and week 14
measure: The Zung Self-Rating Anxiety Scale (SAS)
timeFrame: Baseline, week 6, and week 14
measure: The Zung Self-Rating Depression Scale (SDS)
timeFrame: Baseline, week 6, and week 14
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & Nanjing Medical University Affiliated Cancer Hospital
state: Jiangsu
city: Yantai
country: China
facility: Yantai Hospital of Traditional Chinese Medicine
state: Shandong
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
Study officials:
affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
name: Jiani Wu, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: