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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 99 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "Participants will also complete questionnaires evaluating how hot flashes affect daily activities and quality of life."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares acupuncture with sham (not real) acupuncture to see if it helps reduce hot flashes and improve quality of life. It is for men with prostate cancer who are getting hormone therapy or received it in the past two years.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a history of prostate cancer and get hormone therapy now or have received it in the past two years.
  • Have hot flashes at least twice a day. You may take any number of medicines for hot flashes.
  • Have an ECOG activity score of 3, meaning you need help caring for yourself and spend more than half your waking hours in bed or a chair.
  • You may receive other cancer treatments along with hormone therapy or join other prostate cancer treatment studies if you meet this study’s rules.
  • If cancer spread to your brain and was treated, follow-up brain scans must show it is not getting worse.
  • If cancer in your brain is new or getting worse, or has spread to the tissue around your brain and spinal cord, your doctor must decide that treatment for it is not needed right away and likely will not be needed during the first treatment cycle.
  • You may have another cancer now or have had one in the past.
  • Be able to understand the study and agree to join in writing. A legally authorized person may give this permission for you.

Who can't join

  • Cannot travel for acupuncture visits.
  • Have a high risk of bleeding, as judged by the lead study doctor.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

KY