To hear about similar clinical trials, please enter your email below
Trial Title:
An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues
NCT ID:
NCT05540392
Condition:
Survivorship
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
Acupuncture
Urinary issue
Nocturia
22-270
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Procedure
Intervention name:
Acupuncture
Description:
10 treatments of acupuncture over the course of 10 weeks
Arm group label:
Acupuncture
Intervention type:
Other
Intervention name:
Waitlist Control
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.
Arm group label:
Waitlist Control
Intervention type:
Other
Intervention name:
Questionnaires
Description:
Patients will complete Patient Reported Outcomes (PRO)
Arm group label:
Acupuncture
Arm group label:
Waitlist Control
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.
Criteria for 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
Gender:
Male
Gender based:
Yes
Gender description:
Prostate cancer
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Memorial Sloan Kettering Basking Ridge
Address:
City:
Basking Ridge
Zip:
07920
Country:
United States
Facility:
Name:
Memorial Sloan Kettering Monmouth
Address:
City:
Middletown
Zip:
07748
Country:
United States
Facility:
Name:
Memorial Sloan Kettering Bergen
Address:
City:
Montvale
Zip:
07645
Country:
United States
Facility:
Name:
Memorial Sloan Kettering Cancer Center Suffolk - Commack
Address:
City:
Commack
Zip:
11725
Country:
United States
Facility:
Name:
Memorial Sloan Kettering Westchester
Address:
City:
Harrison
Zip:
10604
Country:
United States
Facility:
Name:
MSK at Ralph Lauren (Consent Only)
Address:
City:
New York
Zip:
10035
Country:
United States
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Facility:
Name:
Memorial Sloan Kettering Nassau
Address:
City:
Uniondale
Zip:
11553
Country:
United States
Start date:
September 9, 2022
Completion date:
September 2025
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05540392
http://www.mskcc.org/mskcc/html/44.cfm
