Acupuncture Versus Sham Acupuncture or Usual Care for Antiandrogen-Induced Hot fLashes in Prostate Cancer (AVAIL) (AVAIL)
Hot Flashes, Prostate Cancer, Acupuncture
About this trial
This is an interventional supportive care trial for Hot Flashes focused on measuring Prostate Cancer, Hot Flashes, Acupuncture, Randomized Controlled Trial
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.
Sites / Locations
- West China HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Sham Comparator
No Intervention
Acupuncture
Sham Acupuncture
Usual Care
Licensed acupuncturists with more than 5 years of experience will be responsible for administering interventions three times per week for 6 weeks. The needles (30 or 40 mm and 0.25 mm gauge; Soochow, Hwato) will be inserted and manipulated until De Qi, a sensation of soreness and tingling. Acupuncture was defined as targeting the 10 bilateral acupuncture points: Xinshu (BL15), Shenshu (BL23), Zhongliao (BL33), Sanyinjiao (SP6), Yinlingquan (SP9). The needle will be left in place for 30 minutes with brief manipulation at the beginning, middle, and end of therapy.
Treatment will be the same for the sham acupuncture, except for the following: the acupuncturist selected the same number of nonacupuncture, nontrigger points. Instead of eliciting De Qi, the needles will be minimally manipulated to avoid eliciting sensations other than initial contact with skin.
Patients receiving usual care received neither acupuncture nor sham acupuncture. After the 6-week assessment, patients will be offered the option to receive acupuncture treatment as the acupuncture group.