Acupuncture vs Sham Acupuncture for Hot Flashes in Prostate Cancer on Hormone Therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, interventional study compares real acupuncture to sham acupuncture for managing hot flashes in men receiving androgen deprivation therapy for prostate cancer. Participants will receive acupuncture during a defined treatment period and complete daily hot flash diaries plus quality-of-life questionnaires to track changes in frequency, severity, and daily impact. Outcomes include hot flash frequency and severity, as well as interference with sleep, mood, and daily activities. Patient-reported measures used are the Hot Flash Daily Diary and the Hot Flash Related Daily Interference Scale. The trial aims to determine if acupuncture can provide symptom relief and QoL benefits in this population.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Kentucky
  Lexington, Kentucky, United States Recruiting

Study contacts

• Study coordinator: Zin Myint, MD
• Email: zwmy222@uky.edu
• Phone: 850-323-3964

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.