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

February 2, 2026 updated by: Inova Health Care Services

MPOWER: A Pilot Trial Among Men With Prostate Cancer: Optimizing Wellness by Enhanced Relief From Hot Flashes With Acupuncture

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a pilot feasibility randomized controlled trial designed to evaluate the acceptability, feasibility, and delivery of an acupuncture intervention for men with prostate cancer receiving androgen deprivation therapy (ADT). A total of 24 participants will be enrolled and randomized in a 1:1 ratio to either an intervention arm with immediate acupuncture (IA) or a wait-list attention control arm with delayed acupuncture (DA), resulting in 12 participants per group. Randomization will be conducted using a simple randomization scheme.

Participants will be followed for a total of 22 weeks. Those assigned to the IA arm will receive a standardized acupuncture protocol consisting of weekly 30-minute manual acupuncture sessions for 10 weeks, administered by a certified acupuncturist with expertise in oncology care. In addition to acupuncture, participants in the IA arm will receive lifestyle education consistent with usual clinical practice. Following completion of the 10-week acupuncture period, participants in the IA arm will enter a 12-week follow-up phase without acupuncture treatment.

Participants assigned to the DA arm will receive lifestyle education per usual care during the initial 10-week period without acupuncture, along with scheduled check-ins with study staff to control for attention. At week 12, participants in the DA arm will begin the same standardized acupuncture protocol as the IA arm, consisting of weekly 30-minute sessions for 10 weeks. This design allows all participants to receive the acupuncture intervention while enabling comparison of feasibility and acceptability between immediate and delayed initiation.

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Inova Schar Cancer Institute
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jeanny Aragon-Ching, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate Start Acupuncture
Participants randomized to the immediate start acupuncture (IA) arm will receive a 10-week standard acupuncture protocol, consisting of weekly 30-minute sessions, in addition to lifestyle education per usual care. Acupuncture will be delivered by a certified acupuncturist with expertise in oncology care. Following completion of the 10-week acupuncture period, participants will enter a 12-week follow-up phase during which no acupuncture treatments will be provided.
Other: Acupuncture
Acupuncture is a form of alternative medicine and a component of traditional Chinese medicine (TCM) in which thin needles are inserted into the body
Active Comparator: Delayed Start Acupuncture
Participants randomized to the delayed start acupuncture (DA) arm will receive lifestyle education per usual care without acupuncture during the initial 10-week comparison period. Beginning at week 12, participants will initiate the same 10-week standard acupuncture protocol, consisting of weekly 30-minute sessions delivered by a certified acupuncturist with expertise in oncology care.
Behavioral: Lifestyle Management
lifestyle education per usual care without acupuncture for the first 10 weeks. At week 12, they will begin the acupuncture protocol (weekly 30-minute sessions).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study feasibility - patient enrollment
Time Frame: 12 months
Study feasibility will be measured by patient enrollment rates, defined as the proportion of eligible patients approached about the study who consent to participate.
12 months
Study feasibility - Patient intervention engagement
Time Frame: 18 months
Study feasibility will be measured by patient intervention engagement, defined as the proportion of enrolled patient subjects who attend at least 6 of 10 scheduled acupuncture visits.
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intervention acceptability - quantitative
Time Frame: 11, 17, and 22 weeks
Intervention acceptability will be measured using satisfaction ratings.
11, 17, and 22 weeks
Intervention acceptability - qualitative
Time Frame: 22 weeks
Intervention acceptability will be evaluated using thematic analysis of post-intervention semi-structured interviews.
22 weeks
Hot Flash Severity Score
Time Frame: Baseline, 11, 17, and 22 weeks
The primary patient outcome is the weekly mean hot flash score, which is calculated by multiplying hot flash frequency by severity, as recorded in the Daily Hot Flash Diary (DHFD).
Baseline, 11, 17, and 22 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inova Health Care Services

Investigators

  • Principal Investigator: Jeanny Aragon-Ching, MD, INOVA Schar Cancer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

January 5, 2026

First Submitted That Met QC Criteria

January 5, 2026

First Posted (Actual)

January 13, 2026

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INOVA-2025-152

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be available upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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