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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China Medical University Hospital

Taichung, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diclofenac

Drug

Patients who were diagnosed as breast cancer and met the inclusion criteria will be recruited and randomly assigned to acupuncture group or drug (NSAIDs) group. After each subgroup completing the 4 weeks intervention, all the participants were enter washout period lasting 2 weeks to eliminate the effect of the previous treatment. Crossover was held after washout period and made the patients to have the other treatment in the following 4 weeks. After receiving the case, the third group recorded the pain indicators for the first month, followed by a one-month trial- combination of acupuncture and NSAID treatment, and then followed up for another month after stopping.

Primary outcomes

Acupuncture can improve joint symptoms resulting from aromatase inhibitor and quality of life

Time frame: 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.

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Registry information

Important dates

Study start: 2018
Primary completion: 2021
Study completion: 2021
First posted: Aug 13, 2020
Registry last updated: Jul 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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