NCT04461977

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Instituto Brasileiro de Controle do Cancer · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peripheral Neuropathy Due to Chemotherapy

Interventions

Type	Name	Description
OTHER	True acupuncture	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.
OTHER	Sham acupuncture	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.

Timeline

• Start date: 2020-01-30
• Primary completion: 2023-11-07
• Completion: 2024-03-26
• First posted: 2020-07-08
• Last updated: 2024-05-31

Locations

1 site across 1 country: Brazil