Acupuncture for Stiffness of Joint Related to Aromatase Inhibitors in Patients With Early-Stage Breast Cancer

Study Overview
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Brief Summary
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RATIONALE: Acupuncture may help relieve joint stiffness related to aromatase inhibitors in patients with early-stage breast cancer. PURPOSE: This single arm clinical study aims to evaluate how well acupuncture as a non-pharmacological treatment, works in treating patients with joint stiffness related to aromatase inhibitors (AIs) in patients with early-stage breast cancer.

Detailed Description
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Objectives of this study: Primary objective: To evaluate whether acupuncture as a non-pharmacological treatment, administered twice weekly for 6 weeks can significantly reduce joint stiffness related to AIs in women with early-stage breast cancer as measured by the Western Ontario and McMasters Universities Osteoarthritis (WOMAC) stiffness score at weeks 6. Secondary objectives: To evaluate the effect of acupuncture on joint stiffness measured by the WOMAC stiffness score at weeks 12. To evaluate the effect of acupuncture on joint stiffness measured by the Modified Score for the Assessment of Chronic Rheumatoid Affections of the Hands (M-SACRAH) stiffness score at weeks 6 and weeks 12. To evaluate the effects of acupuncture on quality of life (QOL) assessed by the Functional Assessment of Cancer Therapy-Endocrine Subscales (FACT-ES) at weeks 6 and weeks 12. To evaluate the safety and tolerability of acupuncture in the enrolled patients. To identify potential genetic determinants to response to acupuncture.

Official Title
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Efficacy and Safety of Acupuncture for Relieving Stiffness of Joint Related to Aromatase Inhibitors in Patients With Early-Stage Breast Cancer

Conditions
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Breast Cancer, Stiffness of Hand, Not Elsewhere Classified

Intervention / Treatment
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* Device: Acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of stage I-III breast cancer and free of disease by clinical examination Postmenopausal or premenopausal with ovarian suppression Currently receiving aromatase inhibitors (Anastrozole, Letrozole, or Exemestane) treatment With joint stiffness attributed to the use of aromatase inhibitors Having had joint stiffness for at least 1 months Having had at least 15 days with stiffness in the preceding 30 days Exclusion Criteria: Women with recurrent or metastatic breast cancer Women having finished chemotherapy or radiation therapy less than 1 months prior to enrollment Women with history of bleeding disorder Women with joint stiffness attributed to inflammatory arthritis, such as rheumatoid arthritis, spondy loarthritis and osteoarthritis Women having joint stiffness prior to AI treatment Women that have received treatment of any kind for joint stiffness within the last 3 months Women that have previously received the acupuncture treatment before for any reason

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with stiffness of joint receive acupuncture therapy<br>This is a single arm study. All the enrolled patients will receive acupuncture twice weekly for 6 weeks then once weekly for another 6 weeks. | Device: Acupuncture<br>* Patients with stiffness of joint receive acupuncture therapy twice weekly for 6 weeks and then once weekly for 6 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in stiffness score as measured by the Western Ontario and McMasters Universities Osteoarthritis (WOMAC) | The change in stiffness score as measured by the Western Ontario and McMasters Universities Osteoarthritis (WOMAC) at the end of week 6 of intervention compared to that at baseline. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in stiffness score as measured by the Modified Score for the Assessment of Chronic Rheumatoid Affections of the Hands (M-SACRAH) | The change in stiffness score as measured by the Modified Score for the Assessment of Chronic Rheumatoid Affections of the Hands (M-SACRAH) at the end of week 6 of intervention compared to that at baseline. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, Stiffness, Aromatase inhibitor, Acupuncture, High altitude