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

NCT04511832 | Completed DMC

• 1 other identifier: CMUH106-REC3-137
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Acupuncture

Outcome Measures

Primary Outcomes (1)

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

  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.

  one year

Study Arms (3)

Acupuncture to NSAIDs

EXPERIMENTAL

Drug: Diclofenac

NSAIDs to Acupuncture

EXPERIMENTAL

Drug: Diclofenac

Combined both acupuncture and NSAIDs

EXPERIMENTAL

Drug: Diclofenac

Interventions

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.

Acupuncture to NSAIDs; Combined both acupuncture and NSAIDs; NSAIDs to Acupuncture

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, Taiwan

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Diclofenac

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• China Medicine University China Medicine University

  China Medicine University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2020
• First Posted: August 13, 2020
• Study Start: March 28, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: July 20, 2022

Record last verified: 2022-07

Locations

TW (1)