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

NCT ID: NCT05069467

Last Updated: 2023-11-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2024-06-30

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.

Conditions

Hot Flashes; Prostate Cancer; Acupuncture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: DEVICE

For the active acupuncture group, the acupuncturist chose standard points depending on subjects' preferred positions. In addition, up to four acupuncture points were chosen on the basis of subjects' other presenting symptoms (such as fatigue, insomnia, or erectile dysfunction). 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.

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.

Group Type: SHAM_COMPARATOR

Sham Acupuncture

Intervention Type: DEVICE

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Acupuncture

For the active acupuncture group, the acupuncturist chose standard points depending on subjects' preferred positions. In addition, up to four acupuncture points were chosen on the basis of subjects' other presenting symptoms (such as fatigue, insomnia, or erectile dysfunction). 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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Other Intervention Names

Placebo Needle; Non-penetrating Acupuncture

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

West China Hospital

OTHER

Sponsor Role: collaborator

Yantai Hospital of Traditional Chinese Medicine

UNKNOWN

Sponsor Role: collaborator

Affiliated Hospital of Nanjing University of Chinese Medicine

OTHER

Sponsor Role: collaborator

Jiangsu Cancer Institute & Hospital

OTHER

Sponsor Role: collaborator

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Jiani Wu

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jiani Wu, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Locations

Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & Nanjing Medical University Affiliated Cancer Hospital

Nanjing, Jiangsu, China

Site Status: RECRUITING

Yantai Hospital of Traditional Chinese Medicine

Yantai, Shandong, China

Site Status: RECRUITING

West China Hospital

Chengdu, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jiani Wu, M.D., Ph.D.

Role: CONTACT

jiani_wu@aliyun.com

13426116653

Zongshi Qin, PhD

Role: CONTACT

arisq@connect.hku.hk

17888808861

Facility Contacts

Xiao Li, MD, PhD

Role: primary

Zhiwei Zang, MD

Role: primary

Jianqin Lv, MD

Role: primary

References

Qin Z, Zang Z, Yu J, Lv J, Li N, Zhang J, Yang M, Kwong JSW, Pang R, Wang J, Cui Z, Yu Y, Wang H, Zhu Y, Yuan Y, Li X, Wu Y, Wu J. Acupuncture versus sham acupuncture and usual care for Antiandrogen-Induced hot fLashes in prostate cancer (AVAIL): study protocol for a randomized clinical trial. BMC Complement Med Ther. 2023 Oct 27;23(1):388. doi: 10.1186/s12906-023-04218-y.

Reference Type: DERIVED

PMID: 37891531 (View on PubMed)

Other Identifiers

2020030KY02

Identifier Type: -

Identifier Source: org_study_id