AccupunctureNCT07594002
Comparing Acupuncture vs. Sham Acupuncture for the Management of Hot Flashes in Prostate Cancer Patients Receiving Hormone Therapy
A study testing Real Acupuncture in people with Accupuncture and Prostate Cancer, run by University of Kentucky at 1 site in United States.
Trial summary
This study is evaluating whether acupuncture may help reduce hot flashes in men receiving hormone therapy for prostate cancer. Hot flashes are a common side effect of androgen deprivation therapy (ADT) and may negatively affect sleep, mood, concentration, daily activities, and overall quality of life. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Accupuncture, Prostate Cancer, Hormone Therapy
- What is being tested?
- Real Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2026to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with history of prostate cancer with currently receiving hormone therapy or had received hormone therapy in the past two years
- Hormone therapies may include androgen deprivation therapy ( ADT; e.g., leuprolide, degarelix, or relugolix) or androgen signaling inhibitors (e.g., enzalutamide, apalutamide, or darolutamide) or adrenal steroid synthesis inhibitor (e.g., abiraterone acetate).
- Patients may also receive additional treatments such as chemotherapy, radioligand therapy or target therapy in combination with hormone therapy.
- Reports hot flashes at least twice per day. Patients may already be taking medications for hot flashes. There is no limit on the number of hot flash medications they can be using.
- ECOG performance status =3 (see Appendix A).
- Patients may participate in other therapeutic clinical trials for the treatment of prostate cancer. They will remain eligible as long as they meet the eligible criteria.
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- Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.
- Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy.
- Patients with a prior or concurrent malignancy are eligible for this trial.
- Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.
Who cannot join
- Patients can't travel for acupuncture
- Patients with high bleeding tendency as determined by PI
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kentucky
Lexington, Kentucky, 40536
Zin Myint, MD, zin.myint@uky.edu
Maria Hoover, BS, 859-323-3065, Maria.Hoover@uky.edu
About this study
This study is evaluating whether acupuncture may help reduce hot flashes in men receiving hormone therapy for prostate cancer. Hot flashes are a common side effect of androgen deprivation therapy (ADT) and may negatively affect sleep, mood, concentration, daily activities, and overall quality of life.
Participants enrolled in this study will receive acupuncture treatment over a defined treatment period. The study will assess changes in hot flash frequency, severity, and quality of life using patient questionnaires and symptom diaries. Participants will complete a daily hot flash diary during selected 7-day assessment periods and quality-of-life questionnaires during study visits.
The primary goal of this study is to determine whether acupuncture may improve hot flash symptoms and related quality of life in men undergoing treatment for prostate cancer.
Read the detailed description
Hot flashes are a common and bothersome side effect experienced by men receiving androgen deprivation therapy (ADT) for prostate cancer. Symptoms may include sudden warmth, sweating, flushing, sleep disturbance, fatigue, mood changes, and reduced quality of life. Although medications such as antidepressants may help some patients, these treatments may also cause side effects and are not effective for all individuals. Acupuncture has been studied as a non-drug approach for management of hot flashes, but additional prospective studies are needed in men with prostate cancer receiving ADT.
This study is a prospective clinical study evaluating acupuncture for the management of ADT-related hot flashes in men with prostate cancer. Participants will undergo acupuncture treatment during the active treatment phase according to the study treatment schedule.
The study will evaluate changes in:
Hot flash frequency Hot flash severity Hot flash-related quality of life Interference of hot flashes with daily activities, sleep, mood, and social functioning
Patient-reported outcomes will be collected using standardized symptom assessments, including:
A Hot Flash Daily Diary The Hot Flash Related Daily Interference Scale (HFRDIS)
Participants will complete a daily hot flash diary during predefined 7-day assessment windows at baseline, during treatment, at the end of treatment, and during follow-up. The diary records the number and severity of hot flashes experienced over a 24-hour period. Participants will also complete questionnaires evaluating how hot flashes affect daily activities and quality of life.
The study includes follow-up assessments after completion of acupuncture treatment to evaluate the durability of symptom improvement over time.
The primary objective of the study is to assess whether acupuncture reduces hot flash burden in men receiving ADT for prostate cancer. Secondary objectives include evaluation of quality-of-life outcomes, symptom trajectory over time, treatment feasibility, and patient adherence to acupuncture-based symptom management.
- Conditions
- Accupuncture, Prostate Cancer, Hormone Therapy, Hot Flashes
- Being tested
- Real Acupuncture, Sham Acupuncture
- Keywords
- Prostate Cancer, Hot Flashes, Androgen Deprivation Therapy
- Medical subject headings
- Prostatic Neoplasms, Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real AcupunctureDevice
The Real Acupuncture is administered at bilateral Large Intestine 4, Kidney 7, Kidney 3, and Gall Bladder 39 points using sterile single-use filiform needles. Needles are inserted approximately 20-25 mm with manipulation to achieve de qi sensation and retained for 30 minutes. Treatments are administered twice weekly for 6 weeks.
Sham AcupunctureDevice
The Sham Acupuncture administered at non-acupuncture points bilaterally using sterile single-use filiform needles. Needles are inserted approximately 4-5 mm without manipulation. Needles are retained for 30 minutes. Treatments are administered twice weekly for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Real Acupuncture | Experimental | Participants receive acupuncture administered by a licensed and NCCAOM board certified acupuncturist at predefined acupuncture points twice weekly for 6 weeks followed by a 4 week washout period before participants crossover to the sham acupuncture arm. Receives: Device: Real Acupuncture |
| Sham Acupuncture | Active comparator | Participants receive acupuncture administered by a licensed and NCCAOM board certified acupuncturist at non-acupuncture points twice weekly for 6 weeks followed by a 4 week washout period before participants crossover to the real acupuncture arm. Receives: Device: Sham Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hot Flash Score
Weekly hot flash score will be calculated from a 7-day hot flash diary. Daily hot flash score is calculated as the number of hot flashes per day multiplied by the maximum severity score for that day. Weekly hot flash score is calculated as the sum of daily hot flash scores over 7 days. The primary outcome is the change in weekly hot flash score from baseline to Week 6.
Measured: Baseline and week 6
Secondary outcomes (3)
Change in Hot Flash Related Daily Interference Scale (HFRDIS) Score
Change in Hot Flash Related Daily Interference Scale (HFRDIS) total score from baseline. The HFRDIS is a validated 10-item patient-reported questionnaire assessing the impact of hot flashes on daily functioning and quality of life. Each item is scored from 0 to 10, with higher scores indicating greater interference from hot flashes.
Measured: Baseline, Week 6, Week 16
Proportion of Participants Achieving ≥50% Reduction in Weekly Hot Flash Score
Proportion of participants achieving at least a 50% reduction in weekly hot flash score compared with baseline, based on 7-day hot flash diary assessments.
Measured: Week 6 and Week 16
Change in Mean Daily Hot Flash Frequency
Change in the mean number of daily hot flashes recorded in the 7-day hot flash diary compared with baseline.
Measured: Baseline, Week 6, Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start13 Aug 2026
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AccupunctureStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kentucky
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zin W Myint, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07594002
- Sponsor's protocol ID
- 111460
- Status last verified
- Aug 2026
- First submitted
- 11 May 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Acupuncture vs. Sham Acupuncture for the Management of Hot Flashes in Prostate Cancer Patients Receiving Hormone Therapy
- ClinicalTrials.gov ID
- NCT07594002
- Acronym / sponsor ID
- 111460
- Conditions
- Accupuncture, Prostate Cancer, Hormone Therapy, Hot Flashes
- Keywords
- Prostate Cancer, Hot Flashes, Androgen Deprivation Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of KentuckyUniversity, hospital or other
- Study start
- 13 Aug 2026 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 18 May 2026 (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.
This study is evaluating whether acupuncture may help reduce hot flashes in men receiving hormone therapy for prostate cancer. Hot flashes are a common side effect of androgen deprivation therapy (ADT) and may negatively affect sleep, mood, concentration, daily activities, and overall quality of life.
Participants enrolled in this study will receive acupuncture treatment over a defined treatment period. The study will assess changes in hot flash frequency, severity, and quality of life using patient questionnaires and symptom diaries. Participants will complete a daily hot flash diary during selected 7-day assessment periods and quality-of-life questionnaires during study visits.
The primary goal of this study is to determine whether acupuncture may improve hot flash symptoms and related quality of life in men undergoing treatment for prostate cancer.
Detailed description
Hot flashes are a common and bothersome side effect experienced by men receiving androgen deprivation therapy (ADT) for prostate cancer. Symptoms may include sudden warmth, sweating, flushing, sleep disturbance, fatigue, mood changes, and reduced quality of life. Although medications such as antidepressants may help some patients, these treatments may also cause side effects and are not effective for all individuals. Acupuncture has been studied as a non-drug approach for management of hot flashes, but additional prospective studies are needed in men with prostate cancer receiving ADT.
This study is a prospective clinical study evaluating acupuncture for the management of ADT-related hot flashes in men with prostate cancer. Participants will undergo acupuncture treatment during the active treatment phase according to the study treatment schedule.
The study will evaluate changes in:
Hot flash frequency Hot flash severity Hot flash-related quality of life Interference of hot flashes with daily activities, sleep, mood, and social functioning
Patient-reported outcomes will be collected using standardized symptom assessments, including:
A Hot Flash Daily Diary The Hot Flash Related Daily Interference Scale (HFRDIS)
Participants will complete a daily hot flash diary during predefined 7-day assessment windows at baseline, during treatment, at the end of treatment, and during follow-up. The diary records the number and severity of hot flashes experienced over a 24-hour period. Participants will also complete questionnaires evaluating how hot flashes affect daily activities and quality of life.
The study includes follow-up assessments after completion of acupuncture treatment to evaluate the durability of symptom improvement over time.
The primary objective of the study is to assess whether acupuncture reduces hot flash burden in men receiving ADT for prostate cancer. Secondary objectives include evaluation of quality-of-life outcomes, symptom trajectory over time, treatment feasibility, and patient adherence to acupuncture-based symptom management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real Acupuncture | Experimental | Device: Real AcupunctureParticipants receive acupuncture administered by a licensed and NCCAOM board certified acupuncturist at predefined acupuncture points twice weekly for 6 weeks followed by a 4 week washout period before participants crossover to the sham acupuncture arm. |
| Sham Acupuncture | Active comparator | Device: Sham AcupunctureParticipants receive acupuncture administered by a licensed and NCCAOM board certified acupuncturist at non-acupuncture points twice weekly for 6 weeks followed by a 4 week washout period before participants crossover to the real acupuncture arm. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with history of prostate cancer with currently receiving hormone therapy or had received hormone therapy in the past two years
- Hormone therapies may include androgen deprivation therapy ( ADT; e.g., leuprolide, degarelix, or relugolix) or androgen signaling inhibitors (e.g., enzalutamide, apalutamide, or darolutamide) or adrenal steroid synthesis inhibitor (e.g., abiraterone acetate).
- Patients may also receive additional treatments such as chemotherapy, radioligand therapy or target therapy in combination with hormone therapy.
- Reports hot flashes at least twice per day. Patients may already be taking medications for hot flashes. There is no limit on the number of hot flash medications they can be using.
- ECOG performance status =3 (see Appendix A).
Key exclusion criteria (2 listed)
- Patients can't travel for acupuncture
- Patients with high bleeding tendency as determined by PI
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 |
|---|---|---|
| Real AcupunctureThe Real Acupuncture is administered at bilateral Large Intestine 4, Kidney 7, Kidney 3, and Gall Bladder 39 points using sterile single-use filiform needles. Needles are inserted approximately 20-25 mm with manipulation to achieve de qi sensation and retained for 30 minutes. Treatments are administered twice weekly for 6 weeks. | Device | Real Acupuncture |
| Sham AcupunctureThe Sham Acupuncture administered at non-acupuncture points bilaterally using sterile single-use filiform needles. Needles are inserted approximately 4-5 mm without manipulation. Needles are retained for 30 minutes. Treatments are administered twice weekly for 6 weeks. | Device | Sham Acupuncture |
Primary outcome
Change in Hot Flash Score
Time frame: Baseline and week 6
Weekly hot flash score will be calculated from a 7-day hot flash diary. Daily hot flash score is calculated as the number of hot flashes per day multiplied by the maximum severity score for that day. Weekly hot flash score is calculated as the sum of daily hot flash scores over 7 days. The primary outcome is the change in weekly hot flash score from baseline to Week 6.
3 secondary outcomes
Change in Hot Flash Related Daily Interference Scale (HFRDIS) Score
Time frame: Baseline, Week 6, Week 16
Proportion of Participants Achieving ≥50% Reduction in Weekly Hot Flash Score
Time frame: Week 6 and Week 16
Change in Mean Daily Hot Flash Frequency
Time frame: Baseline, Week 6, Week 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real Acupuncture in people with Accupuncture and Prostate Cancer, run by University of Kentucky at 1 site in United States.
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 10 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zin Myint, MD (850-323-3964, zwmy222@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hot Flash Score (time frame: Baseline and week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.