Vasomotor Symptom Alleviation Through Acupuncture in Patients With Prostate Cancer (VASA Pro)

March 2, 2026 updated by: University College Cork
A pilot study to assess the acceptability and efficacy of acupuncture in alleviating vasomotor symptoms (hot flushes and night sweats) in Irish patients with prostate cancer receiving androgen deprivation therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Cork, Ireland
        • Bons Secours Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • All participants must have a histologically confirmed diagnosis of prostate cancer and currently be treated with androgen deprivation therapy with or without additional prostate cancer therapies.
  • Patients under the care of a Medical Oncologist in either Bons Secours Hospital or Cork University Hospital
  • All participants must be experiencing moderate to severe vasomotor symptoms as defined by a score of 4 or more on the Hot Flash Index.

Exclusion Criteria:

  • Patients under 18.
  • Patients with HFI scores below 4.
  • Patients not currently being treated with androgen deprivation therapy.
  • Patients with contraindications to acupuncture.
  • Patients already receiving acupuncture for vasomotor symptoms.
  • Patients unwilling to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acupuncture
Acupuncture will be given using single use sterile stainless steel 34 gauge (Japanese size: 0.20 X 30 mm) filoform needles. Skin will be swabbed with an alcohol prep pad before acupuncture is administered. Needles will be inserted 0.5 to 1.0 centimetres deep into the skin and gently manipulated to create the deqi sensation. No electrical stimulation will be used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of the intervention
Time Frame: Completed after 6 weeks of acupuncture sessions and repeated 3 months after acupuncture has finished
Specially designed questionnaire
Completed after 6 weeks of acupuncture sessions and repeated 3 months after acupuncture has finished

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in symptom interference scores
Time Frame: Completed after 6 weeks of acupuncture sessions and repeated 3 months after acupuncture has finished
Changes in the Hot Flash Related Daily Interference Scale (HFRDIS). The scale is measured from 0-10, with lower scores indicating a better outcomes
Completed after 6 weeks of acupuncture sessions and repeated 3 months after acupuncture has finished
Changes in sleep quality
Time Frame: Completed after 6 weeks of acupuncture sessions and repeated 3 months after acupuncture has finished
Changes in Pittsburgh Sleep Quality Index (PSQI). Each answer is rated between 0-3, and a higher global score indicates a worse outcome.
Completed after 6 weeks of acupuncture sessions and repeated 3 months after acupuncture has finished

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2024

Primary Completion (Actual)

February 1, 2025

Study Completion (Actual)

October 7, 2025

Study Registration Dates

First Submitted

June 12, 2024

First Submitted That Met QC Criteria

June 18, 2024

First Posted (Actual)

June 25, 2024

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

March 2, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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