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

N/ANot Yet RecruitingNCT07594002

University of Kentucky40 enrolled

Overview

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.

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.

Interventions

Real AcupunctureDEVICE

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.

Sham AcupunctureDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Baseline and week 6

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.