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

Sponsor

Affiliated Hospital of Qinghai University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05099562

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Device: Acupuncture	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

54 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Acupuncture group This is a one-arm study. Breast cancer patients with peripheral neuropathy were measured using the FACT/ GOG-Ntx and EORTC QLQ-CIPN20 scales. Our clinical study included breast cancer patients diagnosed with peripheral neurotoxicity caused by taxanes-based drugs who would receive acupuncture treatment. Neurotoxicity was identified based on NCI-CTCAE 5.0 for daily or almost daily numbness in the hands and feet, tingling, and other symptoms of peripheral neuropathy over the past two to three weeks. Blood samples were collected from patients to detect SNP associated with neurotoxicity.	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.

Arm

Intervention/Treatment

Experimental: Acupuncture group

This is a one-arm study. Breast cancer patients with peripheral neuropathy were measured using the FACT/ GOG-Ntx and EORTC QLQ-CIPN20 scales. Our clinical study included breast cancer patients diagnosed with peripheral neurotoxicity caused by taxanes-based drugs who would receive acupuncture treatment. Neurotoxicity was identified based on NCI-CTCAE 5.0 for daily or almost daily numbness in the hands and feet, tingling, and other symptoms of peripheral neuropathy over the past two to three weeks. Blood samples were collected from patients to detect SNP associated with neurotoxicity.

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.

Outcome Measures

Primary Outcome Measures

FACT/GOG-Ntx [6]
Patients self-reported FACT/ GOG-NTX at 6 weeks (end of treatment).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

The patient was at least 18 years old and had reported grade 1 or higher neuropathic symptoms for more than 2 weeks;
Patients were screened for eligibility by the investigator prior to enrollment, including verification of baseline neuropathic symptoms.
Patients had a diagnosis of stage I, II, or IIIA breast cancer;
Have completed at least 2 weeks of chemotherapy;
Higher scores indicate more severe symptoms;
Voluntarily participate in the clinical trial and sign the informed consent form after informed consent (patients voluntarily accept the treatment and give informed consent);
Eastern Cooperative Oncology Group (ECOG ) score of physical condition (0-1);
Patients with previous local recurrence were eligible;
The basic indexes were consistent, and the blood routine and ECG were normal.

Exclusion Criteria:

patients with needle phobia;
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;
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;
Being pregnant or nursing, or having used acupuncture for peripheral neuropathy within 6 months prior to study entry;
Life expectancy <6 months;
Lymphedema of limbs;