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Acupuncture Treatment of Vasomotor Symptoms in Breast Cancer Patients

NCT05760222 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2023-03-08

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the impact of acupuncture in preventing worsening of hot flashes and sleep disorders in paucisymptomatic premenopausal Breast Cancer (BC) patients undergoing LHRHa plus endocrine therapy.

According to the published data, acupuncture is an effective and long-lasting (6 to 8 months) treatment for severe vasomotor symptoms. Treatment response can be affected by different variables, including intervention timing.

The main question this study aims to answer is:

Can we expect an additional benefit resulting from an early intervention (when patients are still presymptomatic/paucysintomatic) with acupuncture in preventing worsening in terms of frequency/severity of hot flashes and sleep disorders?

Researchers will compare patients randomized in two arms:

Arm A: intervention with acupuncture Arm B: usual care to see if acupuncture is superior to usual care in preventing worsening of hot flashes

Conditions

Interventions

OTHER

Acupuncture

Acupuncture for prevention/early treatment of vasomotor symptoms and sleep impairment in LHRHa induced amenorrhea in Breast Cancer patients

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Stefano Magno · Fondazione policlinico Gemelli - IRCCS

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-25
Primary Completion
2024-05-25
Completion
2024-12-25

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05760222 on ClinicalTrials.gov