NCT06472856

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 25, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

August 30, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2025

Completed
Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

June 12, 2024

Last Update Submit

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

EXPERIMENTAL
Procedure: Acupuncture

Interventions

AcupuncturePROCEDURE

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.

Acupuncture

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Bons Secours Hospital

Cork, Ireland

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

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

Locations