Hot FlashesAVAILNCT05069467
Acupuncture Versus Sham Acupuncture or Usual Care for Antiandrogen-Induced Hot fLashes in Prostate Cancer (AVAIL)
A study testing Acupuncture in people with Hot Flashes and Prostate Cancer, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Hot Flashes, Prostate Cancer, Acupuncture
- What is being tested?
- Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 3 sitesChina
- Study dates
- 1 Jun 2022to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
West China Hospital
Chengdu, Sichuan
Jianqin Lv, MD
Jianqin Lv, MD
- Recruiting
Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & Nanjing Medical University Affiliated Cancer Hospital
Nanjing, Jiangsu
Xiao Li, MD, PhD
- Recruiting
Yantai Hospital of Traditional Chinese Medicine
Yantai, Shandong
Zhiwei Zang, MD
About this study
Official title: Acupuncture Versus Sham Acupuncture or Usual Care for Antiandrogen-Induced Hot fLashes in Prostate Cancer (AVAIL): a Multicenter Randomized Controlled Trial
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.
Read the 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
- Being tested
- Acupuncture, Sham Acupuncture
- Keywords
- Prostate Cancer, Hot Flashes, Acupuncture, Randomized Controlled Trial
- Medical subject headings
- Hot Flashes, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureDevice
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 AcupunctureDevice
Also called Placebo Needle, Non-penetrating 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.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | 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. Receives: Device: Acupuncture |
| Sham Acupuncture | Sham comparator | 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. Receives: Device: Sham Acupuncture |
| Usual Care | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Weekly mean hot flash symptom severity score (HFSSS)
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).
Measured: Baseline to week 6
Secondary outcomes (6)
Weekly mean hot flash symptom severity score (HFSSS)
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).
Measured: Baseline to week 14
Response rate of HFSSS
The responders will be defined according to a 50% reduction of HFSSS
Measured: Baseline, week 6, and week 14
Functional Assessment of Cancer Therapy-Prostate (FACT-P)
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.
Measured: Baseline, week 6, and week 14
International Index of Erectile Function (IIEF-5)
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.
Measured: Baseline, week 6, and week 14
The Zung Self-Rating Anxiety Scale (SAS)
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.
Measured: Baseline, week 6, and week 14
The Zung Self-Rating Depression Scale (SDS)
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.
Measured: Baseline, week 6, and week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start1 Jun 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hot FlashesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomly 2:1:1 allocated to the verum acupuncture (n=60), sham acupuncture (n=30), or usual care (n=30) group.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- West China Hospital, Yantai Penglai Traditional Chinese Medicine Hospital, Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu Cancer Institute & Hospital
- Responsible party
- Principal investigator, Jiani Wu, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Jiani Wu, M.D., Ph.D., Principal investigator, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05069467
- Sponsor's protocol ID
- 2020030KY02
- Acronym
- AVAIL
- Status last verified
- Nov 2023
- First submitted
- 26 Sep 2021
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The deidentified participant data will be shared after publication. Researchers can access the data with a specific purpose and a signed data access agreement.
Publications
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.
PubMed 37891531
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture Versus Sham Acupuncture or Usual Care for Antiandrogen-Induced Hot fLashes in Prostate Cancer (AVAIL): a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05069467
- Acronym / sponsor ID
- AVAIL / 2020030KY02
- Conditions
- Hot Flashes, Prostate Cancer, Acupuncture
- Keywords
- Prostate Cancer, Hot Flashes, Acupuncture, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- West China Hospital, Yantai Penglai Traditional Chinese Medicine Hospital, Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu Cancer Institute & Hospital
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 6 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Patients will be randomly 2:1:1 allocated to the verum acupuncture (n=60), sham acupuncture (n=30), or usual care (n=30) group.
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Device: AcupunctureLicensed 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 Acupuncture | Sham comparator | Device: Sham AcupunctureTreatment 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 | No intervention | –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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureFor 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. | Device | Acupuncture |
| Sham AcupunctureAlso: Placebo Needle, Non-penetrating AcupunctureTreatment 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. | Device | Sham Acupuncture |
Primary outcome
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).
6 secondary outcomes
Weekly mean hot flash symptom severity score (HFSSS)
Time frame: Baseline to week 14
Response rate of HFSSS
Time frame: Baseline, week 6, and week 14
Functional Assessment of Cancer Therapy-Prostate (FACT-P)
Time frame: Baseline, week 6, and week 14
International Index of Erectile Function (IIEF-5)
Time frame: Baseline, week 6, and week 14
The Zung Self-Rating Anxiety Scale (SAS)
Time frame: Baseline, week 6, and week 14
The Zung Self-Rating Depression Scale (SDS)
Time frame: Baseline, week 6, and week 14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Derived from this study: PubMed 37891531Qin 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.
- Individual participant dataSharing planned: Yes. The deidentified participant data will be shared after publication. Researchers can access the data with a specific purpose and a signed data access agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiani Wu, M.D., Ph.D. principal investigator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Hot Flashes and Prostate Cancer, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiani Wu, M.D., Ph.D. (13426116653, jiani_wu@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weekly mean hot flash symptom severity score (HFSSS) (time frame: Baseline to week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05069467, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.