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NCT07909785

AKU Study - Acupuncture for Aromatase Inhibitor-Induced Musculoskeletal Syndrome

Sponsor: Masaryk Memorial Cancer Institute

View on ClinicalTrials.gov

Summary

Third-generation aromatase inhibitors (AIs) represent a standard adjuvant endocrine treatment for postmenopausal and high-risk premenopausal women with hormone receptor-positive early breast cancer. However, aromatase inhibitor-associated musculoskeletal syndrome (AIMSS)-characterized by joint pain, stiffness, and reduced mobility-occurs in approximately 50% of patients and significantly impairs treatment adherence and patient quality of life. Poor adherence to endocrine therapy is associated with reduced overall survival. The purpose of this prospective, randomized (1:1), open-label, parallel-group clinical trial is to evaluate the efficacy, safety, and duration of therapeutic relief of acupuncture in managing AI-induced musculoskeletal symptoms in female patients with early-stage breast cance. A total of 200 participants experiencing AI-related joint pain are randomized either to receive 10 weekly 20-minute sessions of manual acupuncture over 10 weeks or to a control group receiving standard care without acupuncture. Joint pain severity, upper limb muscle strength and dexterity, sleep quality, and psychological distress are evaluated using validated patient-reported outcomes (Brief Pain Inventory \[BPI\], Rheumatoid Arthritis Pain Scale \[RAPS\], Pittsburgh Sleep Quality Index \[PSQI\], and Hospital Anxiety and Depression Scale \[HADS\]) as well as objective physical performance tests (Hand Grip Strength Test and Grip Ability Test) at baseline, 10 weeks, 14 weeks (4 weeks post-intervention), and 22 weeks (3 months post-intervention).

Official title: Acupuncture for Aromatase Inhibitors-related Musculoskeletal Syndrome in Breast Cancer Patients

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2021-10-05

Completion Date

2028-03-31

Last Updated

2026-11-02

Healthy Volunteers

Conditions

Aromatase Inhibitor-Associated Musculoskeletal Syndrome Arthralgia Syndrome Early Breast Cancer (EBC)

Interventions

DEVICE

Manual Acupuncture

Participants undergo 10 weekly sessions of manual acupuncture lasting 20 minutes per session over a total period of 10 weeks. Acupuncture is administered by trained physicians in accordance with STRICTA (Standards for Reporting Interventions in Clinical Trials of Acupuncture) guidelines. Sterile, single-use ENERGY Wuxi Jiajian acupuncture needles (dimensions: 25×0.25 mm, 40×0.25 mm, 40×0.20 mm) are applied at traditional depths. Each session requires mandatory bilateral stimulation of four core acupuncture points: GB41, GB34, TE5, and LI4 (8 needles total). Additional points (such as ST36, BL60, KI3, PC6, CV6, or other points) may be selected based on the participant's individual clinical presentation and are systematically recorded.

Inclusion Criteria: * Histologically confirmed primary invasive hormone receptor-positive (HR+) breast cancer. * Adjuvant therapy with a third-generation aromatase inhibitor (anastrozole, letrozole, or exemestane) for more than 3 months prior to study enrollment. * Postmenopausal status, or premenopausal status under LHRH agonist therapy for \> 30 days prior to study entry with an anticipated duration of use of at least another 1 year. * ECOG Performance Status 0-2. * Aromatase inhibitor-related multi-joint musculoskeletal pain with a baseline Brief Pain Inventory (BPI) pain score \> 3 out of 10 (and a score ≥ 4 at screening visit). * Signed written informed consent. Exclusion Criteria: * Prior acupuncture treatment within 12 months prior to study entry. * Requirement for any ongoing analgesic therapy (NSAIDs, opioid analgesics, topical analgesics). * Use of non-steroidal anti-inflammatory drugs (NSAIDs) ≤ 7 days prior to enrollment and during the following 3 months. * Regular use of psychotropic drugs, hypnotics, or sedatives. * Acute infectious disease within the preceding 14 days. * Use of antibiotics. * Chemotherapy, immunotherapy, or radiotherapy during the preceding 90 days. * Anticoagulant therapy or underlying coagulation/bleeding disorders. * Use of herbal remedies and dietary supplements 7 days before and 3 months after completion of acupuncture. * Systemic or topical immunomodulatory therapy (oral, intramuscular, or intra-articular corticosteroids). * Use of anticonvulsants (e.g., gabapentin, pregabalin). * Bone fractures or orthopedic bone surgery within 12 months prior to enrollment. * Other joint diseases or systemic conditions (e.g., rheumatoid arthritis). * Inability to undergo needle insertion due to skin disorders. * Use of alternative therapies. * Known allergy to metals. * Severe needle phobia. * Any modification of endocrine therapy during the study period, including switching between different aromatase inhibitor agents (results in participant discontinuation).

Locations (1)

Masaryk Memorial Cancer Institute

Brno, Czechia