An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-09

Study Completion Date

2026-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Survivorship Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Acupuncture

Intervention Type PROCEDURE

10 treatments of acupuncture over the course of 10 weeks

Questionnaires

Intervention Type OTHER

Patients will complete Patient Reported Outcomes (PRO)

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.

Group Type EXPERIMENTAL

Waitlist Control

Intervention Type OTHER

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.

Questionnaires

Intervention Type OTHER

Patients will complete Patient Reported Outcomes (PRO)

Interventions

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Acupuncture

10 treatments of acupuncture over the course of 10 weeks

Intervention Type PROCEDURE

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 Type OTHER

Questionnaires

Patients will complete Patient Reported Outcomes (PRO)

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No