Acupuncture Treatment of Vasomotor Symptoms in Breast Cancer Patients

Breast Cancer Clinical Trial

— Acu-HOTFLASH  

Official title:

Early Acupuncture Treatment of Vasomotor Symptoms and Sleep Disorders in Breast Cancer Luteinising Hormone-releasing Hormone Analogues(LHRHa) Induced Menopause: AcuHOTFLASH Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05760222
• Other study ID #: 4523
• Status: Recruiting
• Phase: N/A
• Start date: November 25, 2021
• Est. completion date: December 25, 2024

Study information

• Verified date: February 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Stefano Magno
• Phone: 347 8551052
• Email: stefano.magno[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

This is a prospective randomized clinical trial of superiority of acupuncture compared to usual care for prevention/early treatment of vasomotor symptoms and sleep impairment in LHRHa induced amenorrhea.

The primary endpoint will be a reduction in frequency and intensity of hot flashes in the intervention arm compared to standard care, measured by the Hot Flash Composite Score (HFCS) at 6 months following the protocol. Among the secondary outcomes, sleep quality will be measured by the Pittsburgh Sleep Quality Index (PSQI) and quality of life by the Menopause-specific Quality of Life Questionnaire (MenQOL) and EORTC Quality of Life Questionnaire (EORTC-C30).

A total of 90 premenopausal BC (stage I-III) patients undergoing LHRHa plus Endocrine Therapy (tamoxifen or aromatase inhibitors) after surgery will be randomized 1:1 in two arms:

Arm A: intervention with 10 acupuncture sessions twice per week for 4 weeks followed by 2 more sessions once per week Arm B: usual care

Participants in both arms will report the hot flash frequency and severity daily (HFCS), and will fill three questionnaires (EORTC QLQ-C30, MenQoL, PSQI) according to the following timeline:

T0 (baseline): 6 weeks following the first LHRHa administration T1: 6 weeks from T0 (corresponding to the end of acupuncture protocol for Arm A) T2: 18 weeks from T0 T3: 30 weeks from T0

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 25, 2024
• Est. primary completion date: May 25, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Premenopausal Breast Cancer patients

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

• Informed consent

Exclusion Criteria:

• Ongoing LHRHa during chemotherapy

• Ongoing pharmacological therapy or natural products consumption for vasomotor symptoms

• Metastatic breast cancer

• Ongoing heparin or anticoagulant therapy

• Psychiatric conditions

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Gemelli- IRCCS	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Sleep quality	Sleep quality will be measured by Pittsburgh Sleep Quality Index (PSQI)	PSQI collected 6 months following the protocol.
Secondary	Quality of life (QoL)	QoL will be measured by Menopause-specific Quality of Life Questionnaire (MenQOL) and EORTC Quality of Life Questionnaire (EORTC QLQ-C30).	MenQOL and EORTC QLQ-C30 will be collected 6 months following the protocol.