Genetic Predictors to Acupuncture Response for Arthralgia Induced by Aromatase Inhibitors in Patients With Breast Cancer

November 7, 2021 updated by: Jiuda Zhao, Affiliated Hospital of Qinghai University
Purpose:Acupuncture for arthralgia induced by aromatase inhibitors in patients with breast cancer associated with screening of SNPs.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Aromatase inhibitor-induced arthralgia (AIA) is the most common side effect of aromatase inhibitors (AIs) used in breast cancer , may cause poor adherence to AIs. Studies have shown that acupuncture has a certain therapeutic effect on AIA in breast cancer. In this study, acupuncture was used to relieve the symptoms of arthralgia in patients, and the efficacy of acupuncture was observed by using relevant scales. Currently, studies have shown that AIA in breast cancer patients is related to some biological factors.

At the same time, we collected peripheral blood samples of patients, combined with the reported relevant literature, screened out the single nucleotide polymorphisms(SNP) related to AIA and to guide acupuncture treatment of aromatase Inhibitors induced arthralgia, balance the toxicity of endocrine therapy, and improve compliance and effectiveness.

Study Type

Interventional

Enrollment (Anticipated)

59

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 Locations

  • China
    • Qinghai
      • Xining, Qinghai, China, 810000
        • Recruiting
        • Affiliated Hospital of Qinghai University

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;Currently receiving aromatase inhibitors (Anastrozole, Letrozole, or Exemestane) treatment;
  2. AI-assisted treatment has lasted for more than one month, and there are obvious symptoms of arthralgia ;
  3. Voluntarily participate in the clinical trial and sign the informed consent form after informed consent (patients voluntarily accept the treatment and give informed consent);
  4. Eastern Cooperative Oncology Group (ECOG) score of physical condition (0-1);
  5. Patients with previous local recurrence were eligible, but not patients with distant metastasis;
  6. The basic indexes were consistent, and the blood routine and ECG were normal.

Exclusion Criteria:

  1. Patients with needle phobia;
  2. Low platelet count (<50000); comorbidity with a bleeding disorder; comorbidity with thyroid dysfunction; pregnancy; haemoglobin levels <10 g/dl and haematocrit <30; anaemia on active pharmacological treatment orreceiving blood transfusion or steroids;
  3. Lymphoedematous of limbs;
  4. Patients have a history of acupuncture treatment for 6 months;
  5. Patients were reluctant to participate in the study;
  6. A prior history of inflammation, metabolic disease, or neurotic joints, except for previous treatment with bisphosphonates, steroids, or opioid analgesics.

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acupuncture group
Acupuncture group Patients with breast cancer who experienced AIA were assessed by the Brief Pain Inventory (BPI)scale and McMasters College Osteoarthritis Index Score (WOMAC). Patients who met the criteria for inclusion would receive regular acupuncture treatment. The location of acupuncture is based on the principles of acupuncture treatment in Traditional Chinese medicine. Patients with high scores and obvious pain received standardized acupuncture treatment, and standard acupuncture points and most painful joint (up to 3) specific point. Meanwhile, blood samples of patients were collected, and SNP related to AIA was screened through SNP typing technology.
Device: Acupuncture group
Acupuncture group Patients with breast cancer who experienced AIA were assessed by the Brief Pain Inventory (BPI)scale and McMasters College Osteoarthritis Index Score (WOMAC). Patients who met the criteria for inclusion would receive regular acupuncture treatment. The location of acupuncture is based on the principles of acupuncture treatment in Traditional Chinese medicine. Patients with high scores and obvious pain received standardized acupuncture treatment, and standard acupuncture points and most painful joint (up to 3) specific point. Meanwhile, blood samples of patients were collected, and SNP related to AIA was screened through SNP typing technology.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in arthralgia scores were measured by the BPI
Time Frame: 52 weeks
Changes in arthralgia scores were measured by the Brief Pain Inventory (BPI) before and after acupuncture treatment.
52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in arthralgia scores were measured by the WOMAC scales
Time Frame: 52 weeks
Changes in arthralgia scores were measured by the McMasters College Osteoarthritis Index Score (WOMAC) scales before and after acupuncture treatment.
52 weeks

Collaborators and Investigators

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

Sponsor

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 (Anticipated)

November 25, 2021

Primary Completion (Anticipated)

November 30, 2022

Study Completion (Anticipated)

November 30, 2023

Study Registration Dates

First Submitted

September 27, 2021

First Submitted That Met QC Criteria

November 7, 2021

First Posted (Actual)

November 18, 2021

Study Record Updates

Last Update Posted (Actual)

November 18, 2021

Last Update Submitted That Met QC Criteria

November 7, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AHQU-2021006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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