Clinical trial NCT05099562: Precision Acupuncture in the Treatment of Peripheral Neuropathy After Taxanes Chemotherapy in Breast Cancer
Official title: Precision Acupuncture in the Treatment of Peripheral Neuropathy After Taxanes Chemotherapy in Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: acupuncture
breast cancer
peripheral neuropathy
taxane chemotherapy
Lead sponsor: Affiliated Hospital of Qinghai University
Sponsor class: OTHER
First posted: 2021-10-29
Enrollment: 54
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: 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.

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;

Primary outcomes:
measure: FACT/GOG-Ntx
timeFrame: 6
Secondary outcomes:
Other outcomes:
Locations:
city: Xining
country: China
facility: Affiliated Hospital of Qinghai University
state: Qinghai
Study officials:
References: