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

Primary Purpose

Breast Cancer, Stiffness of Hand, Not Elsewhere Classified

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
Affiliated Hospital of Qinghai University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Breast cancer, Stiffness, Aromatase inhibitor, Acupuncture, High altitude

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. History of stage I-III breast cancer and free of disease by clinical examination
  2. Postmenopausal or premenopausal with ovarian suppression
  3. Currently receiving aromatase inhibitors (Anastrozole, Letrozole, or Exemestane) treatment
  4. With joint stiffness attributed to the use of aromatase inhibitors
  5. Having had joint stiffness for at least 1 months
  6. Having had at least 15 days with stiffness in the preceding 30 days

Exclusion Criteria:

  1. Women with recurrent or metastatic breast cancer
  2. Women having finished chemotherapy or radiation therapy less than 1 months prior to enrollment
  3. Women with history of bleeding disorder
  4. Women with joint stiffness attributed to inflammatory arthritis, such as rheumatoid arthritis, spondy loarthritis and osteoarthritis
  5. Women having joint stiffness prior to AI treatment
  6. Women that have received treatment of any kind for joint stiffness within the last 3 months
  7. Women that have previously received the acupuncture treatment before for any reason

Sites / Locations

  • Affiliated Hospital of Qinghai University, Affiliated Cancer Hospital of Qinghai UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with stiffness of joint receive acupuncture therapy

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 17, 2021
Last Updated
November 9, 2021
Sponsor
Affiliated Hospital of Qinghai University
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1. Study Identification

Unique Protocol Identification Number
NCT05098951
Brief Title
Acupuncture for Stiffness of Joint Related to Aromatase Inhibitors in Patients With Early-Stage Breast Cancer
Official Title
Efficacy and Safety of Acupuncture for Relieving Stiffness of Joint Related to Aromatase Inhibitors in Patients With Early-Stage Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 20, 2021 (Actual)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Affiliated Hospital of Qinghai University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Stiffness of Hand, Not Elsewhere Classified
Keywords
Breast cancer, Stiffness, Aromatase inhibitor, Acupuncture, High altitude

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with stiffness of joint receive acupuncture therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Acupuncture
Intervention Description
Patients with stiffness of joint receive acupuncture therapy twice weekly for 6 weeks and then once weekly for 6 weeks.
Primary Outcome Measure Information:
Title
The change in stiffness score as measured by the Western Ontario and McMasters Universities Osteoarthritis (WOMAC)
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
The change in stiffness score as measured by the Modified Score for the Assessment of Chronic Rheumatoid Affections of the Hands (M-SACRAH)
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
This study just enroll female patients with breast cancer.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dengfeng Ren
Phone
+8613086297659
Email
dengfeng1104@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiuda Zhao
Organizational Affiliation
the Affiliated Hospital of Qinghai University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Affiliated Hospital of Qinghai University, Affiliated Cancer Hospital of Qinghai University
City
Xining
State/Province
Qinghai
ZIP/Postal Code
810000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dengfeng Ren
Phone
+8613086297659
Email
dengfeng1104@126.com

12. IPD Sharing Statement

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

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