Acupuncture for Hot Flashes in Prostate Cancer Patients on Hormone Therapy

This study is comparing two types of acupuncture, Real Acupuncture and Sham Acupuncture, to see if they can help reduce hot flashes in men with prostate cancer who are receiving hormone therapy. Hot flashes are a common side effect of these treatments, like androgen deprivation therapy (ADT), and can affect sleep, mood, and daily activities. The study aims to see if acupuncture can improve hot flash frequency, severity, and overall quality of life. You may be eligible if you are between 18 and 99 years old, have a history of prostate cancer, and are currently receiving or have recently received hormone therapy. The study is currently unclear on its recruitment status and plans to enroll 40 participants.

Study design
This is an interventional study comparing Real Acupuncture to Sham Acupuncture in 40 participants. It is not specified if participants or researchers will know which type of acupuncture is being received.
What's involved
You would receive acupuncture treatments twice a week for 6 weeks. You would also complete daily hot flash diaries and quality-of-life questionnaires during study visits.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures changes in hot flash scores at baseline and week 6, suggesting follow-up at least until the end of the 6-week treatment period.

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NCT07594002

Comparing Acupuncture vs. Sham Acupuncture for the Management of Hot Flashes in Prostate Cancer Patients Receiving Hormone Therapy

Recruiting
NAAges 18–99InterventionalTreatment
University of Kentucky
~40 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:Real AcupunctureSham Acupuncture

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Hot Flash Score
Measured over Baseline and week 6
Accupuncture
Prostate Cancer
Hormone Therapy
Hot Flashes
1 sites across 1 states
Kentucky1

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Eligibility criteria

Inclusion

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.
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.

Exclusion

Patients can't travel for acupuncture
Patients with high bleeding tendency as determined by PI
  • Change in Hot Flash ScoreBaseline 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.