Acupuncture for Urinary Issues in Prostate Cancer Survivors

Recruiting at 7 trial locations

Overseen By Jun Mao, MD, MSCE

Age: 18+

Sex: Male

Trial Phase: Phase 1 & 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: New urinary medications

Disqualifiers: Sleep apnea, Psychiatric disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

Duration: 10 weeks

60 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Acupuncture for Urinary Issues in Prostate Cancer Survivors?

Research shows that acupuncture can help with urinary issues, as seen in studies where it improved urinary symptoms in patients without prostate cancer and helped control urinary incontinence after prostate surgery. ^{1 2 3 4 5}

Is acupuncture safe for prostate cancer survivors with urinary issues?

Acupuncture is generally considered safe for treating various conditions, including chronic prostatitis, with a good safety profile mentioned in research. However, as with any treatment, it's important to consult with a healthcare provider to ensure it's appropriate for your specific situation. ^{1 6 7 8 9}

How is acupuncture different from other treatments for urinary issues in prostate cancer survivors?

Acupuncture is unique because it involves inserting thin needles into specific points on the body to potentially improve urinary symptoms, unlike conventional treatments that may rely on medication or surgery. It is a non-drug approach that can be combined with other therapies, such as pelvic floor muscle training, to enhance its effectiveness. ^{1 2 8 10 11}

What is the purpose of this trial?

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 for nocturia in prostate cancer survivors. Researchers will see if acupuncture is a practical treatment option for prostate cancer survivors with nocturia. The study will also look at the effect acupuncture has on nocturia and other symptoms prostate cancer survivors experience such as insomnia, hot flashes, anxiety, depression, tiredness (fatigue), sexual dysfunction, and cognitive (mental) difficulties.

Research Team

Kevin Liou, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Waitlist Control Experimental Treatment 2 Interventions

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.

Group II: Acupuncture Experimental Treatment 2 Interventions

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.

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

Approved in United States as Acupuncture for:

• Pain management
• Hot flashes
• Fatigue
• Sleep disturbances
• Anxiety
• Depression
• Neuropathy

Approved in European Union as Acupuncture for:

• Pain management
• Hot flashes
• Fatigue
• Sleep disturbances
• Anxiety
• Depression

Approved in China as Acupuncture for:

• Pain management
• Hot flashes
• Fatigue
• Sleep disturbances
• Anxiety
• Depression
• Neuropathy

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

A prospective, randomized pilot trial of acupuncture of the kidney-bladder distinct meridian for lower urinary tract symptoms. [2006]

2. Brazil pubmed.ncbi.nlm.nih.gov

Effectiveness of systemic acupuncture in the control of urinary incontinence following radical prostatectomy: a randomized clinical trial. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Alternative therapies for advanced prostate cancer. What should I tell my patients? [2019]

4. China pubmed.ncbi.nlm.nih.gov

[Effect of electroacupuncture intervention at different phases of post-operation on bladder function in patients undergoing cervical cancer operation]. [2016]

5. United States pubmed.ncbi.nlm.nih.gov

Factors associated with the use of complementary and alternative medicines for prostate cancer by long-term survivors. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Complementary and alternative medicine (CAM) in prostate and bladder cancer. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Electroacupuncture for moderate and severe benign prostatic hyperplasia: a randomized controlled trial. [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

Acupuncture for treating hot flushes in men with prostate cancer: a systematic review. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Acupuncture for chronic prostatitis: A systematic review and meta-analysis protocol. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

A randomized controlled trial for acupuncture combined with conventional therapy in the treatment of pain caused by prostate cancer: Study protocol clinical trial (SPIRIT compliant). [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Acupuncture reflexotherapy in the treatment of sensory urgency that persists after transurethral resection of the prostate: a preliminary report. [2013]