Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
ID07335224

MPOWER: A Pilot Trial Among Men With Prostate Cancer to Evaluate Acupuncture for Relief From Hot Flashes

Led by Inova Health Care Services · Updated on 2026-02-04

24

Participants Needed

1

Research Sites

25 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether acupuncture can help manage bothersome side effects such as hot flashes, poor sleep, and fatigue in men with prostate cancer who are undergoing hormone therapy called androgen deprivation therapy (ADT). This pilot study aims to test the feasibility and acceptability of acupuncture combined with lifestyle education in this group. The study will include 24 men with prostate cancer receiving ADT and explore acupuncture's potential to reduce hot flashes and improve related symptoms. Participants will be randomly assigned to one of two groups: one will start acupuncture immediately, and the other will start after a delay. The immediate group will receive weekly 30-minute acupuncture sessions for 10 weeks alongside lifestyle education, followed by a 12-week follow-up without acupuncture. The delayed group will receive lifestyle education and regular check-ins for the first 10 weeks, then begin the same 10-week acupuncture program. All acupuncture treatments will be delivered by certified acupuncturists with expertise in oncology care. During the study, participants will be followed for about 22 weeks and asked to complete daily hot flash diaries, symptom and quality of life questionnaires, and wear a Fitbit to monitor sleep. Researchers will measure study feasibility through patient enrollment and engagement, acceptability of the acupuncture intervention, and changes in hot flash severity. This pilot study will help determine if a larger trial should be conducted to better understand acupuncture's role in managing hormone therapy side effects in men with prostate cancer.

CONDITIONS

Brief Title

Men With Prostate Cancer: Optimizing Wellness by Enhanced Relief From Hot Flashes With Acupuncture

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 (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
Not Eligible

You will not qualify if you...

  • Severe or uncontrolled concurrent disease, infection, or co-morbidity making enrollment inappropriate
  • Known hypersensitivity to acupuncture needles
  • Any condition impairing ability to comply with study procedures
  • Unable to comply with study requirements
  • Use of acupuncture for hot flashes within 6 months prior to enrollment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 10 weeks

Participants in the immediate start group receive weekly 30-minute acupuncture sessions for 10 weeks along with lifestyle education. Participants in the delayed start group receive lifestyle education without acupuncture during this time.

Weekly visits for acupuncture sessions or check-ins

Follow-up

Duration - 12 weeks

Participants who completed acupuncture enter a 12-week follow-up phase without acupuncture treatments.

Periodic assessments without acupuncture

Treatment

Duration - 10 weeks

Participants in the delayed start group begin weekly 30-minute acupuncture sessions for 10 weeks after the initial 10-week period, alongside lifestyle education.

Weekly visits for acupuncture sessions

Trial Site Locations

Total: 1 location

1

Inova Schar Cancer Institute

Fairfax, Virginia, United States, 22031

Actively Recruiting

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Research Team

M

Melissa F Miller, phD, MPH

B

Bre Azad

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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