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

Part of paid clinical trials in Fairfax, Virginia.

Sponsor
Inova Health Care Services
Study ID
NCT07335224
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Acupuncture — OTHER
    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 Management — BEHAVIORAL
    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 Details

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.

Key Dates

Start date
Jan 8, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.
  • 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.

Primary Outcome Measure

Study feasibility - patient enrollment [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Inova Schar Cancer InstituteFairfaxVirginia22031
Tuyetson Nguyen, MPH
[email protected]
571-472-8175
Melissa Miller, PhD, MPH
[email protected]
(571) 232-8306
Jeanny Aragon-Ching, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Fairfax, VA

By condition
MenopauseProstate cancer
By specialty
Women's healthFertilityOncologyProstate oncologyMen's healthUrology
By research site
Inova Schar Cancer Institute· Fairfax, VA

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