An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Survivorship; Prostate Cancer

Treatments: Procedure: Acupuncture; Other: Waitlist Control; Other: Questionnaires

Study type: Interventional

Funder types: Other

Identifiers

NCT05540392

22-270

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Acupuncture

Experimental group

Description:

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.

Treatment:

Other: Questionnaires

Procedure: Acupuncture

Waitlist Control

Experimental group

Description:

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.

Treatment:

Other: Questionnaires

Other: Waitlist Control