General Information

Age Group

Status

Protocol Number

NCT07335224

Background Information

By establishing an acupuncture treatment regimen, this research will contribute to evidence-based guidelines for incorporating acupuncture as a non-pharmacologic intervention in supportive cancer care, with the potential to enhance quality of life outcomes among men with prostate cancer experiencing treatment-induced hot flashes.

The study is a pilot feasibility study of a randomized controlled trial. A total of 24 study participants will be randomized 1:1 into the intervention arm (immediate acupuncture, IA) or into the wait-list attention control arm (delayed acupuncture, DA), yielding 12 participants per arm, using simple randomization. Participants will be followed for 22 weeks.  

The primary aim of this study is to evaluate the feasibility and acceptability of the study procedures, recruitment strategies, and intervention delivery in a pilot randomized controlled trial investigating an acupuncture intervention for anti-androgen-induced hot flashes in men with prostate cancer. 

For more information, visit https://clinicaltrials.gov/study/NCT07335224

Offered At

Inova Schar Cancer 
8081 Innovation Park Drive 
Fairfax, VA 22031

Inova Fair Oaks Hospital 
3600 Joseph Siewick Drive 
Fairfax, VA 22033

Inova Alexandria Hospital 
4320 Seminary Road, 
Alexandria, VA 22304 
Principal Investigator

Jeanny Aragon-Ching, MD

Eligibility Information

  • 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

Ineligibility Information

  • 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