Clinical trial NCT05540392: An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues
Official title: Nocturia in Prostate Cancer Survivors - Acupuncture Pilot Study (NOCTURNAL)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Survivorship
Prostate Cancer
Keywords: Acupuncture
Urinary issue
Nocturia
22-270
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2022-09-14
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: success
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center Suffolk - Commack
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: New York
country: United States
facility: MSK at Ralph Lauren (Consent Only)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Kevin Liou, MD
role: PRINCIPAL_INVESTIGATOR
References: