NCT05760222

Brief 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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

November 25, 2021

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 27, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 8, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2024

Completed
Last Updated

March 8, 2023

Status Verified

February 1, 2023

Enrollment Period

2.5 years

First QC Date

February 27, 2023

Last Update Submit

February 27, 2023

Conditions

Breast Cancer

Keywords

Breast CancerHot flashesAcupuncture

Outcome Measures

Primary Outcomes (1)

  • Reduction of frequency and intensity of hot flashes following acupuncture treatment

    Hot flashes will be measured by the Hot Flash Composite Score (HFCS)

    HFCS collected for one week, 6 months following the protocol.

Secondary Outcomes (2)

  • Sleep quality

    PSQI collected 6 months following the protocol.

  • Quality of life (QoL)

    MenQOL and EORTC QLQ-C30 will be collected 6 months following the protocol.

Study Arms (2)

Acupuncture arm

EXPERIMENTAL

Intervention with 10 acupuncture sessions twice per week for 4 weeks followed by 2 more sessions once per week

Other: Acupuncture

Usual care arm

NO INTERVENTION

Lifestyle recommendations

Interventions

AcupunctureOTHER

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

Acupuncture arm

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Premenopausal Breast Cancer patients
  • Stage I-III breast cancer patients undergoing LHRHa plus ET (tamoxifen or aromatase inhibitors) after surgery
  • Informed consent

You may not qualify if:

  • Ongoing LHRHa during chemotherapy
  • Ongoing pharmacological therapy or natural products consumption for vasomotor symptoms
  • Metastatic breast cancer
  • Ongoing heparin or anticoagulant therapy
  • Psychiatric conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Gemelli- IRCCS

Rome, 00168, Italy

RECRUITING

Related Publications (2)

  • Mao JJ, Bowman MA, Xie SX, Bruner D, DeMichele A, Farrar JT. Electroacupuncture Versus Gabapentin for Hot Flashes Among Breast Cancer Survivors: A Randomized Placebo-Controlled Trial. J Clin Oncol. 2015 Nov 1;33(31):3615-20. doi: 10.1200/JCO.2015.60.9412. Epub 2015 Aug 24.

    PMID: 26304905BACKGROUND

  • Lesi G, Razzini G, Musti MA, Stivanello E, Petrucci C, Benedetti B, Rondini E, Ligabue MB, Scaltriti L, Botti A, Artioli F, Mancuso P, Cardini F, Pandolfi P. Acupuncture As an Integrative Approach for the Treatment of Hot Flashes in Women With Breast Cancer: A Prospective Multicenter Randomized Controlled Trial (AcCliMaT). J Clin Oncol. 2016 May 20;34(15):1795-802. doi: 10.1200/JCO.2015.63.2893. Epub 2016 Mar 28.

    PMID: 27022113BACKGROUND

MeSH Terms

Conditions

Breast NeoplasmsHot Flashes

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Stefano Magno

    Fondazione policlinico Gemelli - IRCCS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefano Magno

CONTACT

347 8551052stefano.magno@policlinicogemelli.it

Claudia Maggiore

CONTACT

3498175958claudia.maggiore@guest.policlinicogemelli.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2023

First Posted

March 8, 2023

Study Start

November 25, 2021

Primary Completion

May 25, 2024

Study Completion

December 25, 2024

Last Updated

March 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)