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

November 9, 2021 updated by: Jiuda Zhao, Affiliated Hospital of Qinghai University

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

Recruiting

Conditions

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

Interventional

Enrollment (Anticipated)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Qinghai
      • Xining, Qinghai, China, 810000
        • Recruiting
        • Affiliated Hospital of Qinghai University, Affiliated Cancer Hospital of Qinghai University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Device: Acupuncture
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

This is where you will find people and organizations involved with this study.

Sponsor

Affiliated Hospital of Qinghai University

Investigators

  • Principal Investigator: Jiuda Zhao, The Affiliated Hospital of Qinghai University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 20, 2021

Primary Completion (ANTICIPATED)

September 1, 2022

Study Completion (ANTICIPATED)

June 1, 2023

Study Registration Dates

First Submitted

October 17, 2021

First Submitted That Met QC Criteria

October 17, 2021

First Posted (ACTUAL)

October 29, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 10, 2021

Last Update Submitted That Met QC Criteria

November 9, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AHQU-2021004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on Acupuncture

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe