An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues

Phase 1

Active, not recruiting

• Conditions: Survivorship; Prostate Cancer
• Interventions: Other: Waitlist Control; Procedure: Acupuncture; Other: Questionnaires

• Registration Number: NCT05540392
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-09
• Study First Submitted: 2022-09-09
• Study First Submitted QC: 2022-09-09
• Study First Posted: 2022-09-14
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-10-29
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

• Age 18 or older
• Prior PC diagnosis
• No evidence of Prostate Cancer
• Clinically meaningful nocturia, defined as ≥2 nocturia episodes every night for the past month

Exclusion Criteria

• <1 month since completion of PC treatment (surgery, chemotherapy, radiation, ADT)
• Score of ≥5 on the STOP-Bang questionnaire indicative of high risk of moderate-to severe obstructive sleep apnea
• Other untreated primary sleep disorder (e.g. delayed/advanced sleep phase syndrome)
• Untreated primary psychiatric disorder (e.g. bipolar disorder, schizophrenia, substance abuse, dementia)
• Initiation of new medications for urinary symptoms in the past 4 weeks
• Altered dosing of medications for urinary symptoms in the past 4 weeks
• Plan to initiate/change medications or other treatments (e.g. surgery, behavioral intervention, complementary therapies) for urinary symptoms during the study
• Implanted electronically charged medical device
• Unable to provide consent for himself
• Unwilling to adhere to all study-related procedures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Waitlist Control	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.
Acupuncture	Acupuncture	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.
Waitlist Control	Questionnaires	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.
Acupuncture	Questionnaires	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.

Primary Outcome Measures

Name	Time	Method
success	1 year	If a participant completes at least 8 out of 10 acupuncture sessions. Feasibility will be evaluated based on the respective definitions of success for the acupuncture.

Trial Locations

Locations (8)

Memorial Sloan Kettering Cancer Center Suffolk - Commack; 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Bergen; 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Monmouth; 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Nassau; 🇺🇸 Uniondale, New York, United States

Memorial Sloan Kettering Basking Ridge; 🇺🇸 Basking Ridge, New Jersey, United States

MSK at Ralph Lauren (Consent Only); 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Westchester; 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States