Acupuncture for Stiffness of Joint Related to Aromatase Inhibitors in Patients With Early-Stage Breast Cancer
Efficacy and Safety of Acupuncture for Relieving Stiffness of Joint Related to Aromatase Inhibitors in Patients With Early-Stage Breast Cancer
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dengfeng Ren
- Phone Number: +8613086297659
- Email: dengfeng1104@126.com
Study Locations
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Qinghai
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Xining, Qinghai, China, 810000
- Recruiting
- Affiliated Hospital of Qinghai University, Affiliated Cancer Hospital of Qinghai University
-
Contact:
- Dengfeng Ren
- Phone Number: +8613086297659
- Email: dengfeng1104@126.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Patients with stiffness of joint receive acupuncture therapy
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.
|
Patients with stiffness of joint receive acupuncture therapy twice weekly for 6 weeks and then once weekly for 6 weeks.
|
What is the study measuring?
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)
Time Frame: 6 weeks
|
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)
Time Frame: 6 weeks
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jiuda Zhao, The Affiliated Hospital of Qinghai University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AHQU-2021004
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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