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

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
Affiliated Hospital of Qinghai University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring acupuncture, breast cancer, peripheral neuropathy, taxane chemotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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;

Sites / Locations

  • Affiliated Hospital of Qinghai UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acupuncture group

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 27, 2021
Last Updated
November 9, 2021
Sponsor
Affiliated Hospital of Qinghai University
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1. Study Identification

Unique Protocol Identification Number
NCT05099562
Brief Title
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

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Anticipated)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Affiliated Hospital of Qinghai University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
acupuncture, breast cancer, peripheral neuropathy, taxane chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Acupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
FACT/GOG-Ntx
Description
Patients self-reported FACT/ GOG-NTX at 6 weeks (end of treatment).
Time Frame
6

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiuda Zhao, MD
Phone
13327661976
Email
jiudazhao@126.com
Facility Information:
Facility Name
Affiliated Hospital of Qinghai University
City
Xining
State/Province
Qinghai
ZIP/Postal Code
810000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiuda Zhao, M.D.
Phone
+8613327661976
Email
jiudazhao@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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