An interventional study of Acupuncture and Lifestyle Management in Hot Flashes, Acupuncture Therapy and Vasomotor Symptoms, sponsored by Inova Health Care Services. Recruiting at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-04.
Sponsored by Inova Health Care Services · Not applicable, Interventional, and Supportive care
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.
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.
339 studies on the registry are indexed under Hot Flashes; 56 are open to participants now.
This study's planned enrollment of 24 is below the median of 90 across 306 interventional studies indexed under Hot Flashes.
Browse Hot Flashes studies →Inova Health Care Services is the lead sponsor of 86 studies on the registry; 20 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 8 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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 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 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.
Time frame: 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.
Time frame: 18 months
Intervention acceptability - quantitative
Intervention acceptability will be measured using satisfaction ratings.
Time frame: 11, 17, and 22 weeks
Intervention acceptability - qualitative
Intervention acceptability will be evaluated using thematic analysis of post-intervention semi-structured interviews.
Time frame: 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).
Time frame: Baseline, 11, 17, and 22 weeks
Plan to share: No — Data will be available upon reasonable request.
No publications or documents are linked to this record.
Started Jan 2026 (actual). Primary completion is estimated for Dec 2026, 11 months after the start.
Of 56 non-industry interventional studies with no phase under Hot Flashes, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 11 months is below that.
Counting every sponsor, half of 65 studies reached it within 22 months; a quarter within 10 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
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