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

Primary Purpose

Breast Cancer

Status

Completed

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Diclofenac

About this trial

This is an interventional other trial for Breast Cancer focused on measuring Acupuncture

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

China Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Acupuncture to NSAIDs

NSAIDs to Acupuncture

Combined both acupuncture and NSAIDs

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04511832

First Posted

July 24, 2020

Last Updated

July 18, 2022

Sponsor

China Medical University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04511832

Brief Title

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

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

March 28, 2018 (Actual)

Primary Completion Date

December 31, 2021 (Actual)

Study Completion Date

December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

China Medical University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

Acupuncture

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

54 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Acupuncture to NSAIDs

Arm Type

Experimental

Arm Title

NSAIDs to Acupuncture

Arm Type

Experimental

Arm Title

Combined both acupuncture and NSAIDs

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Diclofenac

Intervention Description

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 Outcome Measure Information:

Title

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

Description

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

China Medicine University China Medicine University

Organizational Affiliation

China Medicine University

Official's Role

Study Chair

Facility Information:

Facility Name

China Medical University Hospital

City

Taichung

Country

Taiwan

12. IPD Sharing Statement

Learn more about this trial

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

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