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

NCT07335224 | Recruiting

• 1 other identifier: INOVA-2025-152
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Androgen Deprivation Therapy; Prostatic Neoplasms; Vasomotor Symptoms; Hot Flashes; Acupuncture Therapy

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  18 months

Secondary Outcomes (3)

• Intervention acceptability - quantitative

  11, 17, and 22 weeks

• Intervention acceptability - qualitative

  22 weeks

• Hot Flash Severity Score

  Baseline, 11, 17, and 22 weeks

Study Arms (2)

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.

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.

Behavioral: Lifestyle Management

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

Immediate Start Acupuncture

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).

Delayed Start Acupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inova Health Care Services: lead

Study Sites (1)

Inova Schar Cancer Institute

Fairfax, Virginia, 22031, United States

RECRUITING

MeSH Terms

Conditions

Hot Flashes; Prostatic Neoplasms

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Jeanny Aragon-Ching, MD

  Inova Schar Cancer

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa F Miller, phD, MPH

CONTACT

(571) 232-8306; melissa.miller@inova.org

Bre Azad

CONTACT

(703) 634-8843; bre.azad@inova.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 13, 2026
• Study Start: January 8, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)