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Completed

NCT Number: NCT06472856

Vasomotor Symptom Alleviation Through Acupuncture in Patients With Prostate Cancer

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Bons Secours Hospital

Cork, Ireland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acupuncture

Procedure

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.

Primary outcomes

  1. Feasibility of the intervention

    Time frame: Completed after 6 weeks of acupuncture sessions and repeated 3 months after acupuncture has finished

    Specially designed questionnaire

Secondary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

University College Cork

Other

Collaborators

  • Bon Secours Hospital, Cork

Registry information

Acronym: VASA Pro

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 25, 2024
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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