Official Title
Precision Acupuncture in the Treatment of Peripheral Neuropathy After Taxanes Chemotherapy in Breast Cancer
Brief Title
Precision Acupuncture in the Treatment of Peripheral Neuropathy After Taxanes Chemotherapy in Breast Cancer
Protocol ID
NCT05099562
Lead Sponsor
Affiliated Hospital of Qinghai University
Brief Summary
Precision Acupuncture in the Treatment of Peripheral Neuropathy After Taxane Chemotherapy
in Breast Cancer
Detailed Description
Associated peripheral neuropathy in breast cancer patients has a significant impact on
their quality of life and treatment compliance. Many studies have shown that acupuncture
has a certain therapeutic effect on peripheral neuropathy. Studies have shown that taxane
induced peripheral neuropathy in breast cancer is related to genetic factors. Based on
SNPs related to peripheral neuropathy, this study screened SNPs related to peripheral
neuropathy caused by taxane drugs, and established a prognostic model.
Eligible patients diagnosed with stage I, II or IIIA breast cancer and experiencing
peripheral neuropathy for at least 2 weeks were assessed by the Functional Assessment of
Cancer Therapy/Gynaecologic Oncology Group-Neurotoxicity,FACT/GOG-Ntx) and the European
Organisation of Research and Treatment of Cancer Quality of Life Questionnaire-CIPN
twenty-item scale(EORTC QLQ-CIPN20). Likert level 5 and level 4 scores were used for all
items in the above two scales. The investigators will temporarily divide the study into a
group, and the investigators will increase the group if necessary. Laboratory personnel
were blinded to all clinical and outcome data.
Study Period
-
Enrollment Count
54 participants
Eligibility Criteria
Inclusion Criteria:
1. The patient was at least 18 years old and had reported grade 1 or higher neuropathic
symptoms for more than 2 weeks;
2. Patients were screened for eligibility by the investigator prior to enrollment,
including verification of baseline neuropathic symptoms.
3. Patients had a diagnosis of stage I, II, or IIIA breast cancer;
4. Have completed at least 2 weeks of chemotherapy;
5. Higher scores indicate more severe symptoms;
6. Voluntarily participate in the clinical trial and sign the informed consent form
after informed consent (patients voluntarily accept the treatment and give informed
consent);
7. Eastern Cooperative Oncology Group (ECOG ) score of physical condition (0-1);
8. Patients with previous local recurrence were eligible;
9. The basic indexes were consistent, and the blood routine and ECG were normal.
Exclusion Criteria:
1. patients with needle phobia;
2. Low platelet count (<50 000); co-morbidity with a bleeding disorder; comorbidity
with thyroid dysfunction; pregnancy; haemoglobin levels <10 g/dl and haematocrit
<30; anaemia on active pharmacological treatment or receiving blood transfusion or
steroids;
3. having metastatic or recurrent disease, history of preexisting peripheral neuropa-
thy prior to chemotherapy, uncontrolled seizure disorder, unstable cardiac disease
or myocardial infarction within 6 months prior to study entry;
4. Being pregnant or nursing, or having used acupuncture for peripheral neuropathy
within 6 months prior to study entry;
5. Life expectancy <6 months;
6. Lymphedema of limbs;
Filters
Breast Cancer
NA
UNKNOWN
ADULT
OLDER_ADULT