Recruiting

Acupuncture

Sponsor:

Inova Health Care Services

Code:

NCT07335224

Conditions

Hot Flashes

Acupuncture Therapy

Vasomotor Symptoms

Androgen Deprivation Therapy

Prostatic Neoplasms

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Acupuncture

Lifestyle Management

Study Details

Brief 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). 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.

Conditions

Hot Flashes

Acupuncture Therapy

Vasomotor Symptoms

Androgen Deprivation Therapy

Prostatic Neoplasms

Study ID

NCT07335224

Start date

Jan 8, 2026

Status verified date

Feb, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

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

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).

Primary outcome measure

  • Study feasibility - patient enrollment [ Time Frame: 12 months ]
  • Study feasibility - Patient intervention engagement [ Time Frame: 18 months ]

Central Contacts and Locations

Central contacts

Locations

Inova Schar Cancer Institute

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Principal Investigator:

Jeanny Aragon-Ching, MD

More Information

Sponsor

Inova Health Care Services

Last update posted

Feb 4, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Inova Health Care Services on 2026-02-04.