Comparative Effectiveness of Acupuncture and Nonsteroidal Anti-inflammatory Drugs for the Management of Aromatase Inhibitor Induced Arthralgia Among Breast Cancer Survivors

China Medical University

Status: Completed

Conditions: Breast Cancer

Treatments: Drug: Diclofenac

Study type: Interventional

Funder types: Other

Identifiers

NCT04511832

CMUH106-REC3-137

Details and patient eligibility

About

Hormone therapy is used to treat women with hormone receptor-positive breast cancer and aromatase inhibitor (AI) is administered after menopause. AI therapy has been proven to be effective in improving the disease-free survival rate, decreasing the recurrence rates and a lower incidence of contralateral breast cancer. However, arthralgia frequently reported as an important adverse event of AI therapy and sometimes resulted in noncompliance with AI therapy. The prevalence of AI induced arthralgia rates ranged from 20 to 74%. Inadequately managed AI induced arthralgia remains a major unmet need in oncology practice in breast cancer survivors.

The goal of this project is to conduct a crossover designed pragmatic clinical trial to evaluate the effectiveness of acupuncture versus NSAID (Diclofenac) for the management of aromatase inhibitor induced arthralgia.

The third group was set to use non-steroidal analgesics plus acupuncture to evaluate the effectiveness of joint pain.

Enrollment: 54 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women who were postmenopausal aged more than 20 years old.
• history of stage 0 to III hormone receptor-positive breast cancer, and currently taking a third-generation AI (anastrozole, letrozole, or exemestane) for at least 3 month.
• Those who reported pain and/or stiffness in one or more joints, which started or worsened after initiation of AI therapy had worst joint pain rated at least three or greater on a 0-10 numerical rating scale in the preceding week.

Exclusion criteria

• any prior acupuncture use for AI-induced joint symptoms or acupuncture within 1 months before entry
• inflammatory, metabolic, or neuropathic arthropathies
• bone fracture/surgery of an afflicted extremity during the preceding 6 months
• allergy to NSAID
• current use of narcotics
• bleeding or coagulation disorders
• localized skin infections
• needle phobia
• intra-articular corticosteroid within 4 weeks preceding the study
• any severe chronic or uncontrolled comorbid disease

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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54 participants in 3 patient groups

Acupuncture to NSAIDs

Experimental group

Treatment:

Drug: Diclofenac

NSAIDs to Acupuncture

Experimental group

Treatment:

Drug: Diclofenac

Combined both acupuncture and NSAIDs

Experimental group

Treatment:

Drug: Diclofenac