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

NCT05125432 | Unknown

• 1 other identifier: AHQU-2021006
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose:Acupuncture for arthralgia induced by aromatase inhibitors in patients with breast cancer associated with screening of SNPs.

Conditions

Breast Cancer

Keywords

Single Nucleotide Polymorphisms; Breast Cancer; Aromatase Inhibitors; Arthralgia; Acupuncture

Outcome Measures

Primary Outcomes (1)

• 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.

  52 weeks

Secondary Outcomes (1)

• Changes in arthralgia scores were measured by the WOMAC scales

  52 weeks

Study Arms (1)

Acupuncture group

EXPERIMENTAL

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

Interventions

Acupuncture group DEVICE

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.

Acupuncture group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Affiliated Hospital of Qinghai University: lead

Study Sites (1)

Affiliated Hospital of Qinghai University

Xining, Qinghai, 810000, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Arthralgia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: November 18, 2021
• Study Start: November 25, 2021
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2023
• Last Updated: November 18, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)