Comparing Acupuncture vs. Sham Acupuncture for the Management of Hot Flashes in Prostate Cancer Patients Receiving Hormone Therapy
University of Kentucky
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.
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 s…
Eligibility
- Age range
- 18–99 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DeviceReal 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.
- DeviceSham 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.
Location
- University of KentuckyLexington, Kentucky