Vasomotor Symptom Alleviation Through Acupuncture in Patients With Prostate Cancer

Not Applicable

Active, not recruiting

• Conditions: Prostate Cancer
• Interventions: Procedure: Acupuncture

• Registration Number: NCT06472856
• Lead Sponsor: University College Cork

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-12
• Study First Submitted QC: 2024-06-18
• Study First Posted: 2024-06-25
• Study Start: 2024-08-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-15
• Last Update Posted: 2024-10-16
• Primary Completion: 2025-03-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acupuncture	Acupuncture	-

Primary Outcome Measures

Name	Time	Method
Feasibility of the intervention	Completed after 6 weeks of acupuncture sessions and repeated 3 months after acupuncture has finished	Specially designed questionnaire

Secondary Outcome Measures

Name	Time	Method
Changes in symptom interference scores	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
Changes in sleep quality	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.

Trial Locations

Locations (1)

Bons Secours Hospital; 🇮🇪 Cork, Ireland