[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07594002":3,"trial-entities:NCT07594002":112,"trial-summary:NCT07594002":116},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":22,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":41,"secondary_outcomes":46,"sex":58,"minimum_age":59,"maximum_age":60,"healthy_volunteers":61,"eligibility_criteria":62,"std_ages":78,"locations":81,"central_contacts":104,"overall_officials":109,"references":110,"see_also_links":111},"NCT07594002","111460","Comparing Acupuncture vs. Sham Acupuncture for the Management of Hot Flashes in Prostate Cancer Patients Receiving Hormone Therapy","RECRUITING","2028-08-31","2026-08","2026-08-18","2026-08-13","University of Kentucky","OTHER",true,"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.\n\nParticipants 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.\n\nThe 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.\n\nThis 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.\n\nThe study will evaluate changes in:\n\nHot flash frequency Hot flash severity Hot flash-related quality of life Interference of hot flashes with daily activities, sleep, mood, and social functioning\n\nPatient-reported outcomes will be collected using standardized symptom assessments, including:\n\nA Hot Flash Daily Diary The Hot Flash Related Daily Interference Scale (HFRDIS)\n\nParticipants 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.\n\nThe study includes follow-up assessments after completion of acupuncture treatment to evaluate the durability of symptom improvement over time.\n\nThe 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.",[18,19,20,21],"Accupuncture","Prostate Cancer","Hormone Therapy","Hot Flashes",[19,21,23],"Androgen Deprivation Therapy","INTERVENTIONAL","TREATMENT",[27],"NA",{"count":29,"type":30},40,"ESTIMATED",[32,37],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DEVICE","Real 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.",[34],{"type":33,"name":38,"description":39,"armGroupLabels":40},"Sham 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.",[38],[42],{"measure":43,"description":44,"timeFrame":45},"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",[47,51,55],{"measure":48,"description":49,"timeFrame":50},"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.","Baseline, Week 6, Week 16",{"measure":52,"description":53,"timeFrame":54},"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.","Week 6 and Week 16",{"measure":56,"description":57,"timeFrame":50},"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.","ALL","18 Years","99 Years",false,{"inclusion":63,"exclusion":74,"raw_text":77},[64,65,66,67,68,69,70,71,72,73],"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.",[75,76],"Patients can't travel for acupuncture","Patients with high bleeding tendency as determined by PI","Inclusion Criteria:\n\n* Patients with history of prostate cancer with currently receiving hormone therapy or had received hormone therapy in the past two years\n* 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).\n* Patients may also receive additional treatments such as chemotherapy, radioligand therapy or target therapy in combination with hormone therapy.\n* 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.\n* ECOG performance status =3 (see Appendix A).\n* 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.\n* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.\n* 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.\n* Patients with a prior or concurrent malignancy are eligible for this trial.\n* 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.\n\nExclusion Criteria:\n\n* Patients can't travel for acupuncture\n* Patients with high bleeding tendency as determined by PI",[79,80],"ADULT","OLDER_ADULT",[82],{"facility":12,"status":7,"city":83,"state":84,"zip":85,"country":86,"contacts":87,"geoPoint":101},"Lexington","Kentucky","40536","United States",[88,92,96,98],{"name":89,"role":90,"email":91},"Zin Myint, MD","CONTACT","zin.myint@uky.edu",{"name":93,"role":90,"phone":94,"email":95},"Maria Hoover, BS","859-323-3065","Maria.Hoover@uky.edu",{"name":89,"role":97},"PRINCIPAL_INVESTIGATOR",{"name":99,"role":100},"Courtney Lantz, Dipl. Ac., L. Ac","SUB_INVESTIGATOR",{"lat":102,"lon":103},37.98869,-84.47772,[105,108],{"name":89,"role":90,"phone":106,"email":107},"850-323-3964","zwmy222@uky.edu",{"name":93,"role":90,"phone":94,"email":95},[],[],[],{"nct_id":4,"conditions":113,"biomarkers":115},[114],"Prostate Carcinoma",[],{"nct_id":4,"found":14,"summary":117,"prompt_version":127},{"design":118,"status":119,"heading":120,"summary":121,"follow_up":122,"word_count":123,"commitments":124,"compensation":125,"drugs_mentioned":126},"This is an interventional study comparing Real Acupuncture to Sham Acupuncture in 40 participants. It is not specified if participants or researchers will know which type of acupuncture is being received.","completed","Acupuncture for Hot Flashes in Prostate Cancer Patients on Hormone Therapy","This study is comparing two types of acupuncture, Real Acupuncture and Sham Acupuncture, to see if they can help reduce hot flashes in men with prostate cancer who are receiving hormone therapy. Hot flashes are a common side effect of these treatments, like androgen deprivation therapy (ADT), and can affect sleep, mood, and daily activities. The study aims to see if acupuncture can improve hot flash frequency, severity, and overall quality of life. You may be eligible if you are between 18 and 99 years old, have a history of prostate cancer, and are currently receiving or have recently received hormone therapy. The study is currently unclear on its recruitment status and plans to enroll 40 participants.","The primary endpoint measures changes in hot flash scores at baseline and week 6, suggesting follow-up at least until the end of the 6-week treatment period.",117,"You would receive acupuncture treatments twice a week for 6 weeks. You would also complete daily hot flash diaries and quality-of-life questionnaires during study visits.","Not stated in the trial record.",[34,38],"v2"]