Acupuncture for Hot Flashes

ZM
Overseen ByZin Myint, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Kentucky
Must be taking: Hormone therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether acupuncture can reduce hot flashes in men undergoing hormone therapy for prostate cancer. Hot flashes can disrupt sleep, mood, and daily life, so finding effective relief is important. Participants will receive either real acupuncture or sham (fake) acupuncture to determine any difference in symptoms. This trial suits men who experience at least two hot flashes a day during hormone treatments for prostate cancer. As an unphased trial, it offers a unique opportunity to contribute to understanding alternative relief methods for hot flashes.

Do I have to stop taking my current medications for the trial?

The trial does not require you to stop taking your current medications for hot flashes. You can continue using them while participating in the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that acupuncture is generally a safe treatment. Research indicates that many people, including those experiencing menopause, tolerate it well. One study on acupuncture for hot flashes in menopausal women found no major safety issues. Participants reported feeling better, whether they received real or sham acupuncture. Other research also supports acupuncture as a safe option for managing hot flashes and similar symptoms. Although the exact mechanism of acupuncture remains unclear, these findings suggest it is a low-risk way to help manage hot flashes.12345

Why are researchers excited about this trial?

Most treatments for hot flashes, like hormone replacement therapy and certain antidepressants, work by altering hormone levels or brain chemicals. But acupuncture offers a unique approach by aiming to balance the body's energy flow, known as "Qi." Researchers are excited about this because acupuncture could provide a non-drug alternative with fewer side effects. Additionally, the use of both real and sham acupuncture in trials helps to determine the true effectiveness of this ancient practice, potentially leading to a new, holistic option for managing hot flashes.

What evidence suggests that acupuncture might be an effective treatment for hot flashes?

This trial will compare the effects of real acupuncture and sham acupuncture on hot flashes. Research has shown that acupuncture might help with hot flashes. In some studies, participants who received real acupuncture experienced a significant decrease in hot flashes. For instance, one small study reported a 76% reduction in hot flashes with genuine acupuncture. However, other research indicates that both real and sham (fake) acupuncture often have similar effects, with both leading to about a 40% decrease in hot flashes that lasts for months. Studies that combine results from multiple studies suggest acupuncture can reduce the frequency and severity of hot flashes, improving quality of life. Overall, while results vary, evidence suggests that acupuncture could be helpful for managing hot flashes.14678

Are You a Good Fit for This Trial?

This trial is for men with prostate cancer who are currently receiving or have recently received hormone therapy and experience at least two hot flashes per day. Participants can be on other treatments, including medications for hot flashes, and must be able to give informed consent.

Inclusion Criteria

* Patients may participate in other therapeutic clinical trials for the treatment of prostate cancer. They will remain eligible as long as they meet the eligible criteria.
I am receiving hormone therapy for my cancer.
I have prostate cancer and am receiving or recently received hormone therapy.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive acupuncture or sham acupuncture twice weekly for 6 weeks

6 weeks
12 visits (in-person)

Washout

A 4-week washout period before crossover to the other treatment arm

4 weeks

Crossover Treatment

Participants crossover to receive the alternate treatment (real or sham acupuncture) twice weekly for 6 weeks

6 weeks
12 visits (in-person)

Follow-up

Participants are monitored for durability of symptom improvement over time

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Real Acupuncture
  • Sham Acupuncture

Trial Overview

The study compares real acupuncture to sham (placebo) acupuncture in a crossover design to see if acupuncture helps reduce the number and severity of hot flashes in men undergoing hormone therapy for prostate cancer.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Real AcupunctureExperimental Treatment1 Intervention
Group II: Sham AcupunctureActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Kentucky

Lead Sponsor

Trials
198
Recruited
224,000+

Citations

The effect of TCM acupuncture on hot flushes among ... - PMC

A small RCT (n = 16) found genuine acupuncture more effective than sham-acupuncture, with a 76% reduction in flushes [19]. An unpublished Norwegian case ...

Acupuncture for menopausal hot flushes - PMC

Key findings: When acupuncture was compared with sham acupuncture, there was no evidence of any difference in their effect on hot flushes. When acupuncture was ...

Real acupuncture for hot flushes is no better than sham, ...

After eight weeks, patients in both groups reported an approximate 40% decrease in hot flushes that was sustained for six months. Mean hot flush ...

How effective is acupuncture in treating hot flashes ...

The results of primary meta-analysis indicated that acupuncture can improved the hot flash symptom scale score (SMD, -0.54; 95% CI, -0.83 to -0.24; P < 0.05).

Real and fake acupuncture have similar effects on hot ...

Women in this study reported improvements in the number and intensity of their hot flashes whether they received the real or the fake treatment ...

Effect of acupuncture on hot flush and menopause symptoms ...

Acupuncture significantly alleviated menopause symptoms, but had no effect on hot flush. Breast cancer patients concerned about the adverse ...

Acupuncture for Menopausal Hot Flashes: A Randomized ...

More than 50% of women use these therapies for menopausal symptoms, despite little evidence of safety and effectiveness (5). Acupuncturists are the second most ...

Effect of acupuncture on hot flush and menopause symptoms ...

The mechanism by which acupuncture leads to physiological or clinical changes is still unclear, but it is widely accepted as a safe treatment[11] ...