Men With Prostate Cancer: Optimizing Wellness by Enhanced Relief From Hot Flashes With Acupuncture
Recruiting · NCT07335224 · Interventional (participants receive a specific treatment) · Lead sponsor: Inova Health Care Services
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Prostate cancer is the most common cancer among men in the United States. Many men with prostate cancer are treated with hormone therapy, also called androgen deprivation therapy (ADT). While this treatment is effective, it often causes bothersome side effects such as hot flashes, poor sleep, fatigue, and other physical and emotional symptoms. There is currently no standard treatment to help manage these side effects in men. Acupuncture is a non-drug treatment that has been shown to help reduce hot flashes and related symptoms in women receiving hormone therapy for breast cancer. However, much less is known about whether acupuncture is helpful for men receiving hormone therapy for prostate cancer. This study will test whether an acupuncture program, combined with usual lifestyle education, is feasible and acceptable for men undergoing ADT. The study will also explore whether acupuncture may help reduce hot flashes and improve related symptoms. A total of 24 men with prostate cancer receiving ADT will be randomly assigned to one of two groups: one group will begin acupuncture right away, and the other group will begin acupuncture after a delay, with regular check-ins during the waiting period. All participants will receive standard lifestyle education. Participants will be followed for about five months and will be asked to complete daily hot flash diaries, questionnaires about their symptoms and quality of life, and wear a Fitbit to track sleep. The results of this pilot study will help determine whether a larger study should be conducted to better understand the role of acupuncture in managing hormone therapy side effects in men with prostate cancer.
Who can take part
Inclusion criteria
- Male
- At least 18 years of age
- Histologically or cytologically confirmed adenocarcinoma of prostate of any stage I-IV
- Undergoing androgen deprivation therapy (ADT) and/or androgen receptor pathway inhibitors
- Experiencing moderate to severe daily interference from hot flashes, as indicated by the Hot Flash Related Daily Interference Scale (score≥4)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Able to read, understand, and provide written informed consent
Exclusion criteria
- Severe or uncontrolled concurrent disease, infection or co-morbidity that, in the opinion of the Investigator, would make the patient inappropriate for enrollment
- Known hypersensitivity to the acupuncture needles
- Any condition that in the opinion of the Investigator would impair the patients' ability to comply with the study procedures
- Unable to comply with study requirements
- Use of acupuncture for hot flashes within 6 months prior to enrollment
Where it is running
1 location listed across 1 US state.
- Inova Schar Cancer Institute - Fairfax, Virginia, United States