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An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues

Primary Purpose

Survivorship, Prostate Cancer

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Waitlist Control
Questionnaires
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Survivorship focused on measuring Acupuncture, Urinary issue, Nocturia, 22-270

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan Kettering Basking RidgeRecruiting
  • Memorial Sloan Kettering MonmouthRecruiting
  • Memorial Sloan Kettering BergenRecruiting
  • Memorial Sloan Kettering Cancer Center Suffolk - CommackRecruiting
  • Memorial Sloan Kettering WestchesterRecruiting
  • MSK at Ralph Lauren (Consent Only)Recruiting
  • Memorial Sloan Kettering Cancer CenterRecruiting
  • Memorial Sloan Kettering NassauRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Acupuncture

Waitlist Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

success
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 Outcome Measures

Full Information

First Posted
September 9, 2022
Last Updated
October 19, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT05540392
Brief Title
An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues
Official Title
Nocturia in Prostate Cancer Survivors - Acupuncture Pilot Study (NOCTURNAL)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 9, 2022 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Survivorship, Prostate Cancer
Keywords
Acupuncture, Urinary issue, Nocturia, 22-270

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist Control
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Description
10 treatments of acupuncture over the course of 10 weeks
Intervention Type
Other
Intervention Name(s)
Waitlist Control
Intervention 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.
Intervention Type
Other
Intervention Name(s)
Questionnaires
Intervention Description
Patients will complete Patient Reported Outcomes (PRO)
Primary Outcome Measure Information:
Title
success
Description
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.
Time Frame
1 year

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Prostate cancer
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kevin Liou, MD
Phone
646-608-8558
Email
liouk@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Mao, MD, MSCE
Phone
646-608-8552
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Liou, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Basking Ridge
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Liou, MD
Phone
646-608-8559
Facility Name
Memorial Sloan Kettering Monmouth
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Liou, MD
Phone
646-608-8559
Facility Name
Memorial Sloan Kettering Bergen
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Liou, MD
Phone
646-608-8559
Facility Name
Memorial Sloan Kettering Cancer Center Suffolk - Commack
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Liou, MD
Phone
646-608-8558
Facility Name
Memorial Sloan Kettering Westchester
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Liou, MD
Phone
646-608-8558
Facility Name
MSK at Ralph Lauren (Consent Only)
City
New York
State/Province
New York
ZIP/Postal Code
10035
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Liou, MD
Phone
646-608-8558
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Loiu, MD
Phone
646-608-8558
First Name & Middle Initial & Last Name & Degree
Jun Mao, MSCE
Phone
646-608-8552
Facility Name
Memorial Sloan Kettering Nassau
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Liou, MD
Phone
646-608-8559

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan Kettering Cancer Center

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An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues

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