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

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

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

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.

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.