Vasomotor Symptom Alleviation Through Acupuncture in Patients With Prostate Cancer
VASA Pro
1 other identifier
interventional
12
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable prostate-cancer
Started Aug 2024
Shorter than P25 for not_applicable prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2024
CompletedFirst Posted
Study publicly available on registry
June 25, 2024
CompletedStudy Start
First participant enrolled
August 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 7, 2025
CompletedMarch 4, 2026
March 1, 2026
5 months
June 12, 2024
March 2, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Feasibility of the intervention
Specially designed questionnaire
Completed after 6 weeks of acupuncture sessions and repeated 3 months after acupuncture has finished
Secondary Outcomes (2)
Changes in symptom interference scores
Completed after 6 weeks of acupuncture sessions and repeated 3 months after acupuncture has finished
Changes in sleep quality
Completed after 6 weeks of acupuncture sessions and repeated 3 months after acupuncture has finished
Study Arms (1)
Acupuncture
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bon Secours Hospital, Corkcollaborator
- University College Corklead
Study Sites (1)
Bons Secours Hospital
Cork, Ireland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2024
First Posted
June 25, 2024
Study Start
August 30, 2024
Primary Completion
February 1, 2025
Study Completion
October 7, 2025
Last Updated
March 4, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share