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

NCT05099562 | Unknown

• 1 other identifier: AHQU-2021005
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Keywords

acupuncture; breast cancer; peripheral neuropathy; taxane chemotherapy

Outcome Measures

Primary Outcomes (1)

• FACT/GOG-Ntx

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

  6

Study Arms (1)

Acupuncture group

EXPERIMENTAL

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

Interventions

Acupuncture DEVICE

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.

Acupuncture group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Affiliated Hospital of Qinghai University: lead

Study Sites (1)

Affiliated Hospital of Qinghai University

Xining, Qinghai, 810000, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Peripheral Nervous System Diseases

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Central Study Contacts

Jiuda Zhao, MD

CONTACT

13327661976; jiudazhao@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: October 29, 2021
• Study Start: December 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: November 10, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)