Precision Acupuncture in the Treatment of Peripheral Neuropathy After Taxanes Chemotherapy in Breast Cancer

Breast Cancer Clinical Trial

Official title:

Precision Acupuncture in the Treatment of Peripheral Neuropathy After Taxanes Chemotherapy in Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05099562
• Other study ID #: AHQU-2021005
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: November 2021
• Source: Affiliated Hospital of Qinghai University
• Contact: Jiuda Zhao, MD
• Phone: 13327661976
• Email: jiudazhao[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Precision Acupuncture in the Treatment of Peripheral Neuropathy After Taxane Chemotherapy in Breast Cancer

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Peripheral Nervous System Diseases

Intervention

Device:
• Acupuncture
Patients received standardized acupuncture treatment. A blood sample of genomic DNA storage was taken from the back of the hand between the first and second metacarpals. Genotypes were obtained by oligonucleotide ligation/polymerase chain reaction and capillary electrophoresis of peripheral neuropathy-associated SNPs.

Locations

Country	Name	City	State
China	Affiliated Hospital of Qinghai University	Xining	Qinghai

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital of Qinghai University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FACT/GOG-Ntx	Patients self-reported FACT/ GOG-NTX at 6 weeks (end of treatment).	6