Acupuncture Versus Sham Acupuncture or Usual Care for Antiandrogen-Induced Hot fLashes in Prostate Cancer (AVAIL): a Multicenter Randomized Controlled Trial

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
West China Hospital
RECRUITING
Chengdu
Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & Nanjing Medical University Affiliated Cancer Hospital
RECRUITING
Nanjing
Yantai Hospital of Traditional Chinese Medicine
RECRUITING
Yantai
Contact Information
Primary
Jiani Wu, M.D., Ph.D.
jiani_wu@aliyun.com
13426116653
Backup
Zongshi Qin, PhD
arisq@connect.hku.hk
17888808861
Time Frame
Start Date: 2022-06-01
Estimated Completion Date: 2024-06-30
Participants
Target number of participants: 120
Treatments
Experimental: Acupuncture
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.
Sham_comparator: Sham Acupuncture
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.
No_intervention: Usual Care
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.
Sponsors
Leads: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborators: Affiliated Hospital of Nanjing University of Chinese Medicine, Yantai Hospital of Traditional Chinese Medicine, West China Hospital, Jiangsu Cancer Institute & Hospital

This content was sourced from clinicaltrials.gov