Back to resultsGenetic Predictors to Acupuncture Response for Arthralgia Induced by Aromatase Inhibitors in Patients With Breast Cancer
Primary Purpose
Breast Cancer
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Acupuncture group
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Single Nucleotide Polymorphisms, Breast Cancer, Aromatase Inhibitors, Arthralgia, Acupuncture
Eligibility Criteria
Inclusion Criteria:
- History of stage I-III breast cancer and free of disease by clinical examination;Currently receiving aromatase inhibitors (Anastrozole, Letrozole, or Exemestane) treatment;
- AI-assisted treatment has lasted for more than one month, and there are obvious symptoms of arthralgia ;
- Voluntarily participate in the clinical trial and sign the informed consent form after informed consent (patients voluntarily accept the treatment and give informed consent);
- Eastern Cooperative Oncology Group (ECOG) score of physical condition (0-1);
- Patients with previous local recurrence were eligible, but not patients with distant metastasis;
- The basic indexes were consistent, and the blood routine and ECG were normal.
Exclusion Criteria:
- Patients with needle phobia;
- 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;
- Lymphoedematous of limbs;
- Patients have a history of acupuncture treatment for 6 months;
- Patients were reluctant to participate in the study;
- A prior history of inflammation, metabolic disease, or neurotic joints, except for previous treatment with bisphosphonates, steroids, or opioid analgesics.
Sites / Locations
- Affiliated Hospital of Qinghai UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Acupuncture group
Arm Description
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.
Outcomes
Primary Outcome Measures
Changes in arthralgia scores were measured by the BPI
Changes in arthralgia scores were measured by the Brief Pain Inventory (BPI) before and after acupuncture treatment.
Secondary Outcome Measures
Changes in arthralgia scores were measured by the WOMAC scales
Changes in arthralgia scores were measured by the McMasters College Osteoarthritis Index Score (WOMAC) scales before and after acupuncture treatment.
Full Information
NCT ID
NCT05125432
First Posted
September 27, 2021
Last Updated
November 7, 2021
Sponsor
Affiliated Hospital of Qinghai University
1. Study Identification
Unique Protocol Identification Number
NCT05125432
Brief Title
Genetic Predictors to Acupuncture Response for Arthralgia Induced by Aromatase Inhibitors in Patients With Breast Cancer
Official Title
Genetic Predictors to Acupuncture Response for Arthralgia Induced by Aromatase Inhibitors in Patients With Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 25, 2021 (Anticipated)
Primary Completion Date
November 30, 2022 (Anticipated)
Study Completion Date
November 30, 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
5. Study Description
Brief Summary
Purpose:Acupuncture for arthralgia induced by aromatase inhibitors in patients with breast cancer associated with screening of SNPs.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Single Nucleotide Polymorphisms, Breast Cancer, Aromatase Inhibitors, Arthralgia, Acupuncture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Acupuncture group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in arthralgia scores were measured by the BPI
Description
Changes in arthralgia scores were measured by the Brief Pain Inventory (BPI) before and after acupuncture treatment.
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Changes in arthralgia scores were measured by the WOMAC scales
Description
Changes in arthralgia scores were measured by the McMasters College Osteoarthritis Index Score (WOMAC) scales before and after acupuncture treatment.
Time Frame
52 weeks
10. Eligibility
Sex
Female
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;Currently receiving aromatase inhibitors (Anastrozole, Letrozole, or Exemestane) treatment;
AI-assisted treatment has lasted for more than one month, and there are obvious symptoms of arthralgia ;
Voluntarily participate in the clinical trial and sign the informed consent form after informed consent (patients voluntarily accept the treatment and give informed consent);
Eastern Cooperative Oncology Group (ECOG) score of physical condition (0-1);
Patients with previous local recurrence were eligible, but not patients with distant metastasis;
The basic indexes were consistent, and the blood routine and ECG were normal.
Exclusion Criteria:
Patients with needle phobia;
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;
Lymphoedematous of limbs;
Patients have a history of acupuncture treatment for 6 months;
Patients were reluctant to participate in the study;
A prior history of inflammation, metabolic disease, or neurotic joints, except for previous treatment with bisphosphonates, steroids, or opioid analgesics.
Facility Information:
Facility Name
Affiliated 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
Jiuda Zhao, M.D.
Phone
+8613327661976
Email
jiudazhao@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Genetic Predictors to Acupuncture Response for Arthralgia Induced by Aromatase Inhibitors in Patients With Breast Cancer
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