Acupuncture Versus Sham Acupuncture or Usual Care for Antiandrogen-Induced Hot fLashes in Prostate Cancer (AVAIL) (AVAIL)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    240
  • sponsor
    Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Updated on 24 July 2022

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.

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.

Details
Condition Hot Flashes, Prostate Cancer, Acupuncture
Treatment Acupuncture, Sham acupuncture
Clinical Study IdentifierNCT05069467
SponsorGuang'anmen Hospital of China Academy of Chinese Medical Sciences
Last Modified on24 July 2022

Eligibility

Yes No Not Sure

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
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