Acupuncture to ease hot flashes in men on hormone therapy for prostate cancer
MPOWER: A Pilot Trial Among Men With Prostate Cancer: Optimizing Wellness by Enhanced Relief From Hot Flashes With Acupuncture
This trial will test if weekly acupuncture plus lifestyle education can help reduce hot flashes and related symptoms in men receiving androgen deprivation therapy for prostate cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Inova Health Care Services Academic / other |
| Locations | 1 site (Fairfax, Virginia) |
| Trial ID | NCT07335224 on ClinicalTrials.gov |
What this trial studies
This is a pilot randomized controlled feasibility trial enrolling 24 men on ADT who have moderate-to-severe hot-flash related interference. Participants are randomized 1:1 to immediate acupuncture or a wait-list delayed acupuncture control; the acupuncture arm receives weekly 30-minute manual acupuncture for 10 weeks delivered by a certified oncology acupuncturist alongside usual lifestyle education. The delayed arm receives lifestyle education and attention control during the first 10 weeks and then the same 10-week acupuncture course starting at week 12. Participants are followed for 22 weeks to assess feasibility, acceptability, and exploratory effects on hot flash frequency, severity, sleep, fatigue, and related symptoms.
Who should consider this trial
Good fit: Men aged 18 or older with histologically confirmed prostate cancer who are receiving ADT or androgen receptor pathway inhibitors, have moderate-to-severe hot-flash interference (HFRDIS ≥4), and an ECOG performance status of 0–1 are ideal candidates.
Not a fit: Patients with known hypersensitivity to acupuncture needles, recent acupuncture for hot flashes within 6 months, severe uncontrolled medical conditions, inability to comply with in-person visits, or who have only mild hot-flash symptoms are unlikely to benefit from this pilot.
Why it matters
Potential benefit: If successful, the program could reduce hot flashes and improve sleep, fatigue, and overall quality of life without adding medications.
How similar studies have performed: Acupuncture has shown benefit for reducing hot flashes in women receiving breast cancer hormone therapy, but similar evidence in men on ADT is limited and this application is relatively untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Fairfax, Virginia
- Inova Schar Cancer Institute — Fairfax, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Jeanny Aragon-Ching, MD — Inova Schar Cancer
- Study coordinator: Melissa F Miller, phD, MPH
- Email: melissa.miller@inova.org
- Phone: (571) 232-8306
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.