Clinical trial NCT05125432: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: Single Nucleotide Polymorphisms
Breast Cancer
Aromatase Inhibitors
Arthralgia
Acupuncture
Lead sponsor: Affiliated Hospital of Qinghai University
Sponsor class: OTHER
First posted: 2021-11-18
Enrollment: 59
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in arthralgia scores were measured by the BPI
timeFrame: 52 weeks
Secondary outcomes:
measure: Changes in arthralgia scores were measured by the WOMAC scales
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Xining
country: China
facility: Affiliated Hospital of Qinghai University
state: Qinghai
Study officials:
References: