Acupuncture Treatment of Vasomotor Symptoms in Breast Cancer Patients

Trial Title: Acupuncture Treatment of Vasomotor Symptoms in Breast Cancer Patients

NCT ID: NCT05760222

Condition: Breast Cancer

Conditions: Official terms:
Breast Neoplasms

Conditions: Keywords:
Breast Cancer
Hot flashes
Acupuncture

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: Acupuncture
Description: Acupuncture for prevention/early treatment of vasomotor symptoms and sleep impairment in LHRHa induced amenorrhea in Breast Cancer patients
Arm group label: Acupuncture arm

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

Criteria for 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

Gender: Female

Gender based: Yes

Gender description: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Fondazione Policlinico Gemelli- IRCCS

Address:
City: Rome
Zip: 00168
Country: Italy

Status: Recruiting

Start date: November 25, 2021

Completion date: December 25, 2024

Lead sponsor:
Agency: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Agency class: Other

Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05760222