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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05099562
Recruitment Status : Unknown
Verified November 2021 by Jiuda Zhao, Affiliated Hospital of Qinghai University.
Recruitment status was:  Recruiting
First Posted : October 29, 2021
Last Update Posted : November 10, 2021
Sponsor:
Information provided by (Responsible Party):
Jiuda Zhao, Affiliated Hospital of Qinghai University

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : December 1, 2021
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. FACT/GOG-Ntx [ Time Frame: 6 ]
    Patients self-reported FACT/ GOG-NTX at 6 weeks (end of treatment).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05099562


Contacts
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Contact: Jiuda Zhao, MD 13327661976 jiudazhao@126.com

Locations
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China, Qinghai
Affiliated Hospital of Qinghai University Recruiting
Xining, Qinghai, China, 810000
Contact: Jiuda Zhao, M.D.    +8613327661976    jiudazhao@126.com   
Sponsors and Collaborators
Affiliated Hospital of Qinghai University
More Information
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Responsible Party: Jiuda Zhao, Professor, Affiliated Hospital of Qinghai University
ClinicalTrials.gov Identifier: NCT05099562    
Other Study ID Numbers: AHQU-2021005
First Posted: October 29, 2021    Key Record Dates
Last Update Posted: November 10, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jiuda Zhao, Affiliated Hospital of Qinghai University:
acupuncture
breast cancer
peripheral neuropathy
taxane chemotherapy
Additional relevant MeSH terms:
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Breast Neoplasms
Peripheral Nervous System Diseases
Neoplasms by Site
Neoplasms
 Breast Diseases
Skin Diseases
Neuromuscular Diseases
Nervous System Diseases