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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Diclofenac

• Registration Number: NCT04511832
• Lead Sponsor: China Medical University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-28
• Study First Submitted: 2020-07-24
• Study First Submitted QC: 2020-08-11
• Study First Posted: 2020-08-13
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Acupuncture to NSAIDs	Diclofenac	-
NSAIDs to Acupuncture	Diclofenac	-
Combined both acupuncture and NSAIDs	Diclofenac	-

Primary Outcome Measures

Name	Time	Method
Acupuncture can improve joint symptoms resulting from aromatase inhibitor and quality of life	one year	Patients will be asked to complete a baseline questionnaire covering demographic information and reproductive history. At baseline and at 4, 6 and 10 weeks, self-administered questionnaires including the 10mm visual analogue scales. Follow-up assessments will be conducted at the 4 weeks after the end of intervention.; According to statistically estimation, we compare the changes between three subgroups and hypothesize 20% difference as significant effect after intervention. We use ANOVA to calculate the sample size with an alpha of 0.05 as significance level, approximately 80% power and 20% drop-out rate. The trial will enroll 145 participants.

Trial Locations

Locations (1)

China Medical University Hospital; 🇨🇳 Taichung, Taiwan