An Acupuncture Study for Prostate Cancer Survivors with Urinary Issues, the NOCTURNAL Study

Status: closed to accrual

This phase I/II trial studies how well acupuncture works in improving nocturia in prostate cancer survivors. Nocturia is a condition that causes the need to frequently wake up throughout the night to urinate. Some treatments used for cancer can cause long-term side effects, such as nocturia. Acupuncture is a medical technique that involves insertion of very thin needles into specific areas on the body with the goal of promoting health and well-being. It has been widely used to treat pain, but researchers think acupuncture can also improve nocturia and other symptoms that many cancer survivors report following surgery, radiation, chemotherapy, and other cancer treatments.

Inclusion Criteria

Age 18 or older
Prior PC diagnosis
No evidence of PC
Clinically meaningful nocturia, defined as >= 2 nocturia episodes every night for the past month the past month

Exclusion Criteria

< 1 month since completion of PC treatment (surgery, chemotherapy, radiation, antiandrogen therapy [ADT])
Score of >= 5 on the snoring, tiredness, observed apnea (STOP)-body mass index, age, neck circumference, gender (Bang) questionnaire indicative of high risk of moderate-to-severe 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 OBJECTIVE:

I. To determine the feasibility of studying acupuncture for nocturia in prostate cancer (PC) survivors.

SECONDARY OBJECTIVE:

I. To evaluate the preliminary effects of acupuncture on nocturia and co-morbid symptoms in PC survivors.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients undergo acupuncture on study.

GROUP II: Patients undergo a waiting period and then have the option to undergo acupuncture on study.

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An Acupuncture Study for Prostate Cancer Survivors with Urinary Issues, the NOCTURNAL Study

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