Acupuncture for Treatment of Peripheral Neuropathy Induced by Neoadjuvant or Adjuvant Paclitaxel in Early Stage Breast Cancer: a Sham Controlled, Randomized Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peripheral Neuropathy Due to Chemotherapy
- Sponsor
- Instituto Brasileiro de Controle do Cancer
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- The change the effects of neuropathic pain syndromes management from baseline
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age \>= 18 years old.
- •Agreed to sign the Informed Consent Term
- •Breast cancer stages I, II and III.
- •Received adjuvant or neoadjuvant chemotherapy containing weekly paclitaxel 80 mg/m
- •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.
Outcomes
Primary Outcomes
The change the effects of neuropathic pain syndromes management from baseline
Time Frame: Screening visit (baseline), week 4, week 6, week 8, week 12
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.
Secondary Outcomes
- Baseline pain intensity change(Screening visit (baseline), week 4, week 6, week 8, week 12)
- Change in side effects associated with taxane treatments from baseline(Screening visit (baseline), week 4, week 6, week 8, week 12)