- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06472856
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
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
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Cork, Ireland
- Bons Secours Hospital
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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.
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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
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Specially designed questionnaire
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Completed after 6 weeks of acupuncture sessions and repeated 3 months after acupuncture has finished
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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
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Changes in the Hot Flash Related Daily Interference Scale (HFRDIS).
The scale is measured from 0-10, with lower scores indicating a better outcomes
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Completed after 6 weeks of acupuncture sessions and repeated 3 months after acupuncture has finished
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Changes in sleep quality
Time Frame: Completed after 6 weeks of acupuncture sessions and repeated 3 months after acupuncture has finished
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Changes in Pittsburgh Sleep Quality Index (PSQI).
Each answer is rated between 0-3, and a higher global score indicates a worse outcome.
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Completed after 6 weeks of acupuncture sessions and repeated 3 months after acupuncture has finished
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24017
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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