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

NCT07594002 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-05-18

No results posted yet for this study

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.

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.

Conditions

  • Accupuncture
  • Prostate Cancer
  • Hormone Therapy
  • Prostate Cancer Hot Flashes Androgen Deprivation Therapy-Related Hot Flashes

Interventions

DEVICE

Real Acupuncture

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.

DEVICE

Sham Acupuncture

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.

Sponsors & Collaborators

  • University of Kentucky

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-05
Primary Completion
2028-05-31
Completion
2028-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07594002 on ClinicalTrials.gov