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

Instituto Brasileiro de Controle do Cancer

Status: Completed

Conditions: Peripheral Neuropathy Due to Chemotherapy

Treatments: Other: True acupuncture; Other: Sham acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT04461977

26778919.3.0000.0072

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

A - true acupuncture

Experimental group

Description:

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.

Treatment:

Other: True acupuncture

B - sham acupuncture

Sham Comparator group

Description:

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.

Treatment:

Other: Sham acupuncture