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

NCT07594002 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 111460
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Prostate Cancer Hot Flashes Androgen Deprivation Therapy-Related Hot Flashes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Hot Flash Related Daily Interference Scale (HFRDIS) Score

  Baseline, Week 6, Week 16

• Proportion of Participants Achieving ≥50% Reduction in Weekly Hot Flash Score

  Week 6 and Week 16

• Change in Mean Daily Hot Flash Frequency

  Baseline, Week 6, Week 16

Study Arms (2)

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.

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.

Device: Sham Acupuncture

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.

Real Acupuncture

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.

Sham Acupuncture

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Kentucky: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Zin Myint, MD

CONTACT

850-323-3964; zwmy222@uky.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 18, 2026
• Study Start (Estimated): June 5, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: May 18, 2026

Record last verified: 2026-05

Locations

US (1)