Acupuncture for CIPN in Breast Cancer Patients

Study Overview
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Brief Summary
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The aim of this study is to collect preliminary data on the effectiveness of acupuncture for the treatment of CIPN in breast cancer patients.

Detailed Description
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Ideally 10 patients experiencing peripheral neuropathy due to chemotherapy from breast cancer treatment will be included in this study.They will receive 16 total acupuncture treatments over 10 weeks including various points based off of research and classical text and scalp acupuncture.

Official Title
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Acupuncture for Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer Patients- A Case Series

Conditions
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Sensation Disorders, Neuropathy

Intervention / Treatment
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* Device: Acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Minimum of 18 years of age Currently receiving neurotoxic chemotherapy Experiencing symptoms of chemotherapy induced neuropathy for at least 1 month Have a minimum score of 3 on the VAS should have a grade II CIPN on NCICTC Willing to sign an informed consent Stable treatment for more than two months before screening Stable treatment is defined as no change in the type and dose of medications 2 months prior to enrollment. Once enrolled, the patients will be asked to remain on the same type and dose of the medications for neuropathy Exclusion Criteria: Receiving any treatment to prevent neuropathy 2 weeks prior to the screening Pre-existing peripheral neuropathy due to any other cause than chemotherapy Pre-existing conditions like pregnancy, uncontrolled diabetes, hypertension, cardiovascular disorders, bleeding disorders, depression (BDI > 21) Unwilling to follow the protocol Individuals who are receiving government disability assistance

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture<br>Acupuncture including scalp needling will be applied to selected points based on literature | Device: Acupuncture<br>* Acupuncture twice a week for 6 weeks then one treatment a week for 4 weeks. Total 16 treatments in 10 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in perceived neuropathy as measured by EORTC CIPN-20 | This is a 20-item self-report multidimensional CIPN specific scale that measures sensory, motor and autonomic symptoms of a 1-4 Likert scale. | At baseline, week 6 (treatment 12) and at week 10 (treatment 16) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in perceived neuropathy as measured by Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT-GOG) Questionnaire |  | At baseline, week 6 (treatment 12) and at week 10 (treatment 16) | 
| Changes in perceived neuropathy as measured by Visual Analogue Scale of Pain |  | At baseline, week 6 (treatment 12) and at week 10 (treatment 16) | 
| Changes in quality of life as measured by EORTC QLQ-30 |  | At baseline, week 6 (treatment 12) and at week 10 (treatment 16) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neuropathy, peripheral, chemotherapy, breast cancer