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

Not Applicable

Completed

• Conditions: Peripheral Neuropathy Due to Chemotherapy
• Interventions: Other: Sham acupuncture; Other: True acupuncture

• Registration Number: NCT04461977
• Lead Sponsor: Instituto Brasileiro de Controle do Cancer

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.

Study Timeline

• Study Start: 2020-01-30
• Study First Submitted: 2020-07-02
• Study First Submitted QC: 2020-07-07
• Study First Posted: 2020-07-08
• Primary Completion: 2023-11-07
• Study Completion: 2024-03-26
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-29
• Last Update Posted: 2024-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B - sham acupuncture	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.
A - true acupuncture	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.

Primary Outcome Measures

Name	Time	Method
The change the effects of neuropathic pain syndromes management from baseline	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 Outcome Measures

Name	Time	Method
Baseline pain intensity change	Screening visit (baseline), week 4, week 6, week 8, week 12	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 \[100-mm scale\]).
Change in side effects associated with taxane treatments from baseline	Screening visit (baseline), week 4, week 6, week 8, week 12	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.

Trial Locations

Locations (1)

Instituto Brasileiro de Controle de Cancer (IBCC Oncologia); 🇧🇷 Sao Paulo, SP, Brazil