Nocturia in Prostate Cancer Survivors - Acupuncture Pilot Study (NOCTURNAL)
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 60
- Locations
- 15
- Primary Endpoint
- success
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Acupuncture (Procedure)
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.
Intervention: Questionnaires (Other)
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.
Intervention: Questionnaires (Other)
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.
Intervention: Waitlist Control (Other)
Outcomes
Primary Outcomes
success
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported