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

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
University of Kentucky
Study ID
NCT07594002
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Real Acupuncture — DEVICE
    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 Acupuncture — DEVICE
    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 Details

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.

Key Dates

Start date
Jun 5, 2026
Status verified
May 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Real Acupuncture
    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.
  • Active Comparator: Sham Acupuncture
    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.

Primary Outcome Measure

Change in Hot Flash Score [ Time Frame: Baseline and week 6 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of KentuckyLexingtonKentucky40536
Zin Myint, MD
[email protected]
Zin Myint, MD (PRINCIPAL_INVESTIGATOR)
Courtney Lantz, Dipl. Ac., L. Ac (SUB_INVESTIGATOR)

Find similar trials in Lexington, KY

By condition
MenopauseProstate cancer
By specialty
Women's healthFertilityOncologyProstate oncologyMen's healthUrology
By research site
University of Kentucky· Lexington, KY

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