Acupuncture for Urinary Issues in Prostate Cancer Survivors

Not currently recruiting at 7 trial locations
KL
Jun Mao, MD, MSCE profile photo
Overseen ByJun Mao, MD, MSCE
Age: 18+
Sex: Male
Trial Phase: Phase 1 & 2
Sponsor: Memorial Sloan Kettering Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether acupuncture can reduce nighttime bathroom trips (nocturia) in prostate cancer survivors. Researchers aim to determine if acupuncture can also alleviate related issues such as trouble sleeping, hot flashes, anxiety, depression, fatigue, sexual problems, and memory difficulties. Participants will either receive acupuncture treatments once a week for 10 weeks or join a waitlist group that can opt for acupuncture later. Men previously diagnosed with prostate cancer who experience frequent nighttime bathroom visits (2 or more times every night for the past month) might be suitable for this study. As a Phase 1, Phase 2 trial, this research focuses on understanding how acupuncture works in people and measuring its effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot start new medications or change the dose of medications for urinary symptoms during the study.

What prior data suggests that acupuncture is safe for prostate cancer survivors with nocturia?

Research has shown that acupuncture is generally safe for treating various health issues. A review of many studies found that acupuncture worked better than no treatment for issues like osteoarthritis pain. These studies included over 2,400 people, indicating that many tolerate acupuncture well.

One study focused on acupuncture for urinary problems and found it to be a safe and effective choice. This suggests acupuncture might help with frequent nighttime urination (nocturia) without causing major side effects.

While this trial specifically targets prostate cancer survivors with nocturia, the safety of acupuncture in other conditions is reassuring. Overall, acupuncture appears to be a safe treatment with few reported side effects.12345

Why are researchers excited about this trial?

Researchers are excited about using acupuncture for urinary issues in prostate cancer survivors because it offers a non-drug, holistic approach that might alleviate symptoms without the side effects often associated with medications like alpha-blockers or anticholinergics. Acupuncture is unique in that it stimulates specific points on the body, potentially improving urinary function by enhancing nerve signaling or reducing inflammation. Additionally, it provides a natural alternative that could be especially appealing to patients seeking complementary therapies alongside conventional cancer treatments.

What evidence suggests that acupuncture might be an effective treatment for nocturia in prostate cancer survivors?

Research shows that acupuncture can help with urinary problems in men who have survived prostate cancer. It reduces urinary incontinence, a common issue after prostate surgery. One study found that combining acupuncture with pelvic floor exercises lessened these symptoms. Acupuncture also relieves pain and improves urinary issues in prostate conditions. In this trial, participants in the acupuncture group will receive 10 treatments over 10 weeks. Although this is the first study to explore acupuncture for nighttime urination in prostate cancer survivors, the results suggest it could be beneficial.14567

Who Is on the Research Team?

KL

Kevin Liou, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for prostate cancer survivors over 18 with no current evidence of cancer, experiencing frequent nighttime urination (nocturia). They must not have started new urinary medications or changed doses in the last month and can't have untreated sleep disorders, psychiatric conditions, or be at high risk for obstructive sleep apnea.

Inclusion Criteria

I have been diagnosed with prostate cancer before.
I do not have prostate cancer.
I wake up to urinate 2 or more times every night for the last month.

Exclusion Criteria

I have changed my medication for urinary problems in the last month.
I plan to start or change treatments for urinary symptoms during the study.
I am unable to give consent by myself.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Acupuncture group will receive 10 treatments of acupuncture over the course of 10 weeks (i.e. one treatment a week) with a +/- 14-day window.

10 weeks
10 visits (in-person)

Waitlist Control

The waitlist control group will not receive any acupuncture treatments during the 14-week waiting period. Patients in waitlist control group will have the option to receive up to 10 acupuncture treatments after a 14-week waiting period.

14 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Acupuncture
Trial Overview The study tests if acupuncture can help reduce nocturia in prostate cancer survivors. It's a first-of-its-kind study to see if this traditional technique could also ease insomnia, hot flashes, anxiety, depression, fatigue, sexual dysfunction and cognitive issues related to prostate cancer survivorship.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Waitlist ControlExperimental Treatment2 Interventions
Group II: AcupunctureExperimental Treatment2 Interventions

Acupuncture is already approved in United States, European Union, China for the following indications:

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Approved in United States as Acupuncture for:
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Approved in European Union as Acupuncture for:
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Approved in China as Acupuncture for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Citations

Effectiveness and safety of acupuncture combined with ...The results showed that acupuncture combined with TCM can significantly improve the symptoms of urination, relieve pain, and improve the ...
An Acupuncture Study for Prostate Cancer Survivors ...The purpose of this study is to test whether acupuncture can improve nocturia in prostate cancer survivors. This is the first time acupuncture is being studied ...
Effectiveness of systemic acupuncture in the control ...Acupuncture associated with pelvic floor muscle training was effective in reducing urinary incontinence in prostatectomized men.
Electroacupuncture in Patients With Early Urinary ...Findings In this randomized clinical trial of 110 men, electroacupuncture significantly increased the 6-week UC rate (44% vs 22%) and reduced 24 ...
A narrative review of acupuncture in prostate diseases: ...Acupuncture demonstrates significant efficacy in symptom relief (pain reduction and improvement of urinary symptoms) and disease modification (prostate volume ...
Acupuncture for Nocturia in Survivors of Prostate CancerWe conducted a pilot randomized clinical trial to evaluate acupuncture relative to usual care for nocturia in prostate cancer survivors.
Acupuncture: Effectiveness and Safety - nccIH.nih.govIn a 2018 review, data from 10 studies (2,413 participants) showed acupuncture was more effective than no treatment for osteoarthritis pain, and data from 9 ...
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