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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorUniversity of Kentucky

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

Patients can't travel for acupuncture

Patients with high bleeding tendency as determined by PI

Trial design

Treatments tested in this trial

  • Real Acupuncture
  • Sham Acupuncture

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators