Acupuncture for Peripheral Neuropathy Induced by Paclitaxel in Early Stage Breast Cancer

Study Overview
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Brief Summary
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The present study aims to evaluate the effectiveness of acupuncture in the treatment of chemotherapy drug paclitaxel induced peripheral neuropathy in patients with early stage breast cancer

Detailed Description
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Patients with early stage breast cancer (stages I,II,III) who received paclitaxel in neoadjuvant or adjuvant chemotherapy protocol and developed peripheral neuropathy will be randomized to receive true acupuncture (intervention group) vs sham acupuncture (control), once a week, for 8 weeks. The primary outcome is improvement of the symptoms by Neuropathic Pain Symptom Inventory (NPSI) scale (Bouhassira,2004). The secondary outcomes are improvements on Visual analog scale (VAS) and Quality of life by FACT-taxane (Cella, 2003) questionnaire. These scales will be assessed in the Screening visit (baseline), week 4, week 6, week 8 and week 12. The study has duration of 12 weeks.

Official Title
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Acupuncture for Treatment of Peripheral Neuropathy Induced by Neoadjuvant or Adjuvant Paclitaxel in Early Stage Breast Cancer: a Sham Controlled, Randomized Study

Conditions
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Peripheral Neuropathy Due to Chemotherapy

Intervention / Treatment
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* Other: True acupuncture
* Other: Sham acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >= 18 years old. Agreed to sign the Informed Consent Term ECOG 0-1 Breast cancer stages I, II and III. Received adjuvant or neoadjuvant chemotherapy containing weekly paclitaxel 80 mg/m2. Peripheral sensory neuropathy grade 2 and 3 by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Exclusion Criteria: Previous history of peripheral neuropathy due to other comorbidities. Prior treatment with chemotherapy for cancer other than breast cancer. Use of medications to treat peripheral neuropathy. Metastatic disease. Presence of lymphedema of any degree. History of coagulopathy or full anticoagulation. Previous acupuncture treatment for any indication within the last 90 days.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: True acupuncture vs sham acupuncture
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A - true acupuncture<br>The selection of acupuncture points is based on Traditional Chinese Medicine (Wen 2011) and on previous studies (Jeong, 2018; Bao,2018), selected as main points: bilateral baxie, SJ5, bafeng, KID3 and ST36. Modifications or additional secondary points may be indicated according to clinical judgment throughout treatment. | Other: True acupuncture<br>* The selection of acupuncture points is based on Traditional Chinese Medicine (Wen, 2011) and on previous studies (Jeong,2018; Bao,2018), selected as main points: bilateral baxie, SJ5, bafeng, KID3 and ST36. Modifications or additional secondary points may be indicated according to clinical judgment throughout treatment. The needles will be inserted at a depth of 10 - 15 mm, being gently manipulated to obtain de qi sensation. The needles will be left for 20 - 25 minutes. There will be once a week acupuncture treatment, for 8 consecutive weeks. The acupuncture needles will be sterile, disposable stainless steel needles size 0.20 x 30 mm, of Korean brand Dong Bang, Chungcheongnam-do.<br>|
| Sham Comparator: B - sham acupuncture<br>Patients will receive needling at non-acupuncture points with superficial needling without manipulation to obtain de qi, located near the real points in the hands and feet. | Other: Sham acupuncture<br>* Patients will receive needling at non-acupuncture points with superficial needling without manipulation to obtain de qi, located near the real points in the hands and feet. The needles will also be left for 20 - 25 minutes. There will be once a week acupuncture treatment, for 8 consecutive weeks. There will be once a week acupuncture treatment, for 8 consecutive weeks. The acupuncture needles will be sterile, disposable stainless steel needles size 0.20 x 30 mm, of Korean brand Dong Bang, Chungcheongnam-do.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change the effects of neuropathic pain syndromes management from baseline | Neuropathic Pain Symptom Inventory (NPSI) scale. This tool included 12 items in total: 10 are differential symptoms descriptors and 2 items evaluate spontaneous and paroxysmal spontaneous pain. The verbal numeric scale from zero (no pain) to 10 (worst imaginable pain). Total pain intensity score may be calculated by the sum of 10 descriptors. | Screening visit (baseline), week 4, week 6, week 8, week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline pain intensity change | Visual analog scale (VAS). The pain VAS is a unidimensional measure of pain intensity. It is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length. For pain intensity, the scale is most commonly anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 100 [100-mm scale]). | Screening visit (baseline), week 4, week 6, week 8, week 12 | 
| Change in side effects associated with taxane treatments from baseline | FACT-taxane questionnaire. It is a self-report instrument that was developed to measure the health-related Quality of life of patients receiving taxane-containing chemotherapy. This scale has 16 items, including an 11-item neurotoxicity subscale and five additional taxane-specific questions related to the effects of arthralgia, myalgia, and skin changes. The total score is calculated as the sum of the un-weighted subscale score. | Screening visit (baseline), week 4, week 6, week 8, week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral Neuropathy, Breast Cancer, Chemotherapy, Paclitaxel, Acupuncture