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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hot Flashes; Prostate Cancer; Hormone Therapy; Accupuncture
• Intervention / Treatment: Device: Real Acupuncture; Device: Sham Acupuncture

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zin Myint, MD; Phone Number: 850-323-3964; Email: zwmy222@uky.edu

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University Of Kentucky
      • Contact: Zin Myint, MD; Email: zin.myint@uky.edu
      • Principal Investigator: Zin Myint, MD
      • Sub-Investigator: Courtney Lantz, Dipl. Ac., L. Ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

• Patients can't travel for acupuncture
• Patients with high bleeding tendency as determined by PI

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline, Week 6, Week 16

Collaborators and Investigators

• Sponsor: University of Kentucky

Study record dates

Study Major Dates

• Study Start (Estimated): June 5, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028

Study Registration Dates

• First Submitted: May 11, 2026
• First Submitted That Met QC Criteria: May 11, 2026
• First Posted (Actual): May 18, 2026

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Prostate Cancer; Androgen Deprivation Therapy; Hot Flashes
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Prostatic Neoplasms; Hot Flashes
• Other Study ID Numbers: 111460

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes