- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05069467
Acupuncture Versus Sham Acupuncture or Usual Care for Antiandrogen-Induced Hot fLashes in Prostate Cancer (AVAIL) (AVAIL)
Acupuncture Versus Sham Acupuncture or Usual Care for Antiandrogen-Induced Hot fLashes in Prostate Cancer (AVAIL): a Multicenter Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jiani Wu, M.D., Ph.D.
- Phone Number: 13426116653
- Email: jiani_wu@aliyun.com
Study Contact Backup
- Name: Zongshi Qin, PhD
- Phone Number: 17888808861
- Email: arisq@connect.hku.hk
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China
- Recruiting
- Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & Nanjing Medical University Affiliated Cancer Hospital
-
Contact:
- Xiao Li, MD, PhD
-
-
Shandong
-
Yantai, Shandong, China
- Recruiting
- Yantai Hospital of Traditional Chinese Medicine
-
Contact:
- Zhiwei Zang, MD
-
-
Sichuan
-
Chengdu, Sichuan, China
- Recruiting
- West China hospital
-
Contact:
- Jianqin Lv, MD
-
Principal Investigator:
- Jianqin Lv, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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 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.
|
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.
Other Names:
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weekly mean hot flash symptom severity score (HFSSS)
Time Frame: Baseline to week 6
|
The HFSSS is defined as the product of "hot frequency" and "hot severity".
The severity of hot flashes is assessed based on the duration of hot flashes and physical and emotional symptoms; it is scored as mild, moderate, severe, and very severe (range 1-4, from mild to very severe).
|
Baseline to week 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weekly mean hot flash symptom severity score (HFSSS)
Time Frame: Baseline to week 14
|
The HFSSS is defined as the product of "hot frequency" and "hot severity".
The severity of hot flashes is assessed based on the duration of hot flashes and physical and emotional symptoms; it is scored as mild, moderate, severe, and very severe (range 1-4, from mild to very severe).
|
Baseline to week 14
|
Response rate of HFSSS
Time Frame: Baseline, week 6, and week 14
|
The responders will be defined according to a 50% reduction of HFSSS
|
Baseline, week 6, and week 14
|
Functional Assessment of Cancer Therapy-Prostate (FACT-P)
Time Frame: Baseline, week 6, and week 14
|
The Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire is a relevant, worldwide tool used for assessing the health-related quality of life in men with prostate cancer.
|
Baseline, week 6, and week 14
|
International Index of Erectile Function (IIEF-5)
Time Frame: Baseline, week 6, and week 14
|
The IIEF-15 comprises 15 items divided into 5 domains: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction, respectively.
The IIEF-5 comprises 5 items from the IIEF-15, 4 from the erectile function domain, and 1 from intercourse satisfaction.
Response options for each item ranged from 1 to 5, and occasionally the option "0" depicting no sexual stimulation/intercourse, the scores are summed.
|
Baseline, week 6, and week 14
|
The Zung Self-Rating Anxiety Scale (SAS)
Time Frame: Baseline, week 6, and week 14
|
The SAS consists of 20 items that assess common symptoms of anxiety, such as tension, fear, worry, and nervousness.
Each item is rated on a Likert-type scale ranging from 1 to 4. Scores on the scale can rage from 20 to 80, with higher scores indicating more severe symptoms of anxiety.
|
Baseline, week 6, and week 14
|
The Zung Self-Rating Depression Scale (SDS)
Time Frame: Baseline, week 6, and week 14
|
The SDS is a 20-item measure, with each item rated on a 4-point scale.
It requires approximately 5-10 minutes to complete.
Ranges for mild to moderate depression, moderate to severe depression, and severe depression are 50-59, 60-69, and over 70, respectively.
|
Baseline, week 6, and week 14
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jiani Wu, M.D., Ph.D., Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020030KY02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hot Flashes
-
Mitsubishi Tanabe Pharma America Inc.CompletedMenopause Hot FlashesUnited States
-
University of California, San FranciscoCompleted
-
University of California, San FranciscoCompleted
-
AmgenCompleted
-
Alison Huang, MDNational Institute on Aging (NIA)Completed
-
University of WashingtonEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedTreatment of Menopausal Hot FlashesUnited States
-
Donesta BioscienceSynteractHCRCompleted
-
University of California, San FranciscoNational Center for Complementary and Integrative Health (NCCIH)CompletedHot Flashes | Hot FlushesUnited States
-
National Institutes of Health Clinical Center (CC)National Cancer Institute (NCI)CompletedFever, Sweats, and Hot FlashesUnited States
-
University of PennsylvaniaForest LaboratoriesCompleted
Clinical Trials on Acupuncture
-
Federal University of São PauloCompleted
-
University of ZurichCharite University, Berlin, Germany; First Teaching Hospital of Tianjin University...CompletedExperimental Dental PainSwitzerland
-
University of SkövdeCompleted
-
National Research Centre of Complementary and Alternative...Norwegian Acupuncture CollegeUnknown
-
Chengdu University of Traditional Chinese MedicineChongqing Medical University; Hunan University of Traditional Chinese MedicineCompletedFunctional Dyspepsia | Postprandial Distress SyndromeChina
-
Chang Gung Memorial HospitalRecruitingIntracranial HemorrhagesTaiwan
-
University Medicine GreifswaldRecruitingGagging During Transesophageal EchocardiographyGermany
-
University of MichiganMassachusetts General Hospital; National Center for Complementary and Integrative...Completed
-
Huazhong University of Science and TechnologyThe University of Hong Kong; Heilongjiang University of Chinese Medicine; Hubei...CompletedPolycystic Ovary SyndromeChina
-
China Medical University HospitalNot yet recruiting