Acupuncture to ease hot flashes in men on hormone therapy for prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.