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Status unknownNCT05125432Updated Nov 18, 2021

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

An interventional study of Acupuncture group in Breast Cancer, sponsored by Affiliated Hospital of Qinghai University. Status unknown at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-11-18.

Sponsored by Affiliated Hospital of Qinghai University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
59
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Breast Cancer

Keywords

  • Single Nucleotide Polymorphisms
  • Breast Cancer
  • Aromatase Inhibitors
  • Arthralgia
  • Acupuncture
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 59 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Affiliated Hospital of Qinghai University is the lead sponsor of 17 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
59 participants (estimated)

Study arms

  • 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

Interventions

  • DeviceAcupuncture 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.

06

What researchers measure

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.

    Time frame: 52 weeks

Secondary outcomes

  1. 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.

    Time frame: 52 weeks

07

Study locations

1 of 1 sites recruiting
  • Affiliated Hospital of Qinghai University
    Xining, Qinghai 810000, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05125432
Lead sponsor
Affiliated Hospital of Qinghai University
Responsible party
Jiuda Zhao (Professor, Affiliated Hospital of Qinghai University) — Principal investigator
First posted
Nov 18, 2021
Start date
Nov 25, 2021 (estimated)
Primary completion
Nov 30, 2022 (estimated)
Completion
Nov 30, 2023 (estimated)
Last update
Nov 18, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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