Hot FlashesMPOWERNCT07335224
Men With Prostate Cancer: Optimizing Wellness by Enhanced Relief From Hot Flashes With Acupuncture
A study testing Acupuncture and Lifestyle Management in people with Hot Flashes and Acupuncture Therapy, run by Inova Health Care Services at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hot Flashes, Acupuncture Therapy, Vasomotor Symptoms
- What is being tested?
- Acupuncture and Lifestyle Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
Tuyetson Nguyen, MPH, 571-472-8175, tuyetson.nguyen@inova.org
Melissa Miller, PhD, MPH, (571) 232-8306, melissa.miller@inova.org
About this study
Official title: 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.
Read the 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.
- Conditions
- Hot Flashes, Acupuncture Therapy, Vasomotor Symptoms, Androgen Deprivation Therapy, Prostatic Neoplasms
- Being tested
- Acupuncture, Lifestyle Management
- Medical subject headings
- Hot Flashes, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
Acupuncture is a form of alternative medicine and a component of traditional Chinese medicine (TCM) in which thin needles are inserted into the body
Lifestyle ManagementBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Immediate Start Acupuncture | Experimental | 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. Receives: Other: Acupuncture |
| Delayed Start Acupuncture | Active comparator | 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. Receives: Behavioral: Lifestyle Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study feasibility - patient enrollment
Study feasibility will be measured by patient enrollment rates, defined as the proportion of eligible patients approached about the study who consent to participate.
Measured: 12 months
Study feasibility - Patient intervention engagement
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.
Measured: 18 months
Secondary outcomes (3)
Intervention acceptability - quantitative
Intervention acceptability will be measured using satisfaction ratings.
Measured: 11, 17, and 22 weeks
Intervention acceptability - qualitative
Intervention acceptability will be evaluated using thematic analysis of post-intervention semi-structured interviews.
Measured: 22 weeks
Hot Flash Severity Score
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).
Measured: Baseline, 11, 17, and 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start8 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hot FlashesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inova Health Care Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeanny Aragon-Ching, MD, Principal investigator, Inova Schar Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07335224
- Sponsor's protocol ID
- INOVA-2025-152
- Acronym
- MPOWER
- Status last verified
- Feb 2026
- First submitted
- 5 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MPOWER: A Pilot Trial Among Men With Prostate Cancer: Optimizing Wellness by Enhanced Relief From Hot Flashes With Acupuncture
- ClinicalTrials.gov ID
- NCT07335224
- Acronym / sponsor ID
- MPOWER / INOVA-2025-152
- Conditions
- Hot Flashes, Acupuncture Therapy, Vasomotor Symptoms, Androgen Deprivation Therapy, Prostatic Neoplasms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Inova Health Care ServicesUniversity, hospital or other
- Study start
- 8 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Immediate Start Acupuncture | Experimental | Other: AcupunctureParticipants 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. |
| Delayed Start Acupuncture | Active comparator | Behavioral: Lifestyle ManagementParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureAcupuncture is a form of alternative medicine and a component of traditional Chinese medicine (TCM) in which thin needles are inserted into the body | Other | Immediate Start Acupuncture |
| Lifestyle Managementlifestyle education per usual care without acupuncture for the first 10 weeks. At week 12, they will begin the acupuncture protocol (weekly 30-minute sessions). | Behavioural | Delayed Start Acupuncture |
Primary outcome
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.
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.
3 secondary outcomes
Intervention acceptability - quantitative
Time frame: 11, 17, and 22 weeks
Intervention acceptability - qualitative
Time frame: 22 weeks
Hot Flash Severity Score
Time frame: Baseline, 11, 17, and 22 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: No. Data will be available upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeanny Aragon-Ching, MD principal investigator
Inova Schar Cancer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and Lifestyle Management in people with Hot Flashes and Acupuncture Therapy, run by Inova Health Care Services at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melissa F Miller, phD, MPH ((571) 232-8306, melissa.miller@inova.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study feasibility - patient enrollment (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.