Clinical trial NCT05760222: Acupuncture Treatment of Vasomotor Symptoms in Breast Cancer Patients
Official title: Early Acupuncture Treatment of Vasomotor Symptoms and Sleep Disorders in Breast Cancer Luteinising Hormone-releasing Hormone Analogues(LHRHa) Induced Menopause: AcuHOTFLASH Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Hot flashes
Acupuncture
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-08
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Reduction of frequency and intensity of hot flashes following acupuncture treatment
timeFrame: HFCS collected for one week, 6 months following the protocol.
Secondary outcomes:
measure: Sleep quality
timeFrame: PSQI collected 6 months following the protocol.
measure: Quality of life (QoL)
timeFrame: MenQOL and EORTC QLQ-C30 will be collected 6 months following the protocol.
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Gemelli- IRCCS
Study officials:
affiliation: Fondazione policlinico Gemelli - IRCCS
name: Stefano Magno
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.