Abstract 232TiP
Background
Debilitating symptoms such as hot flashes and sleep deficiency, due to luteinizing hormone-releasing hormone analogues (LHRHa) induced ovarian suppression in premenopausal Breast Cancer (BC) patients, affect quality of life and adherence to endocrine therapies (ET). Pharmacological options available to improve these conditions are limited and often burdened by significant side effects. Acupuncture can be considered for vasomotor symptoms management according to several clinical trials and guidelines, including The National Comprehensive Cancer Network (NCCN) and ESMO Advanced Breast Cancer (ABC) symptom control Guidelines. The aim of this study is to evaluate the impact of acupuncture in preventing worsening in terms of frequency/severity of hot flashes and sleep disorders in paucysintomatic premenopausal BC patients undergoing LHRHa plus endocrine therapy (tamoxifen or aromatase inhibitors).
Trial design
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 between 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 QLQ-C30). A significant reduction in the outbreak of hot flashes and insomnia in the intervention arm would consolidate an evidence-based integration of acupuncture in the management of BC patients undergoing ET, with lower toxicities compared to pharmacological treatments and improved quality of life.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.