Clinical trial NCT04511832: Comparative Effectiveness of Acupuncture and Nonsteroidal Anti-inflammatory Drugs for the Management of Aromatase Inhibitor Induced Arthralgia Among Breast Cancer Survivors
Official title: Comparative Effectiveness of Acupuncture and Nonsteroidal Anti-inflammatory Drugs for the Management of Aromatase Inhibitor Induced Arthralgia Among Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Acupuncture
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2020-08-13
Enrollment: 54
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Acupuncture can improve joint symptoms resulting from aromatase inhibitor and quality of life
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: China Medicine University
name: China Medicine University China Medicine University
role: STUDY_CHAIR
References: