The Use of Acupuncture for Treatment of Chemotherapy-induced Peripheral Neuropathy (CIPN).

Not Applicable

Completed

• Conditions: Neoplasm; Neuropathy; Adult Disease
• Interventions: Procedure: Acupuncture; Behavioral: Orientation group

• Registration Number: NCT02309164
• Lead Sponsor: University of Sao Paulo

Brief Summary

This study aims to determine the effectiveness of the use of acupuncture in relieving sensory and motor symptoms as well as functional impairment and quality of life of patients with chemotherapy induced peripheral neuropathy

Detailed Description

The trial is a clinical, single-center, randomized trial study that will involve 30 adult cancer patients with chemotherapy-induced peripheral neuropathy randomized into two groups (control and acupuncture treated with 10 sessions, 2X per week). Both CIPN patients groups will be submitted to a complete physical examination and to clinical assessments with National Cancer Institute Common Terminology Criteria for Adverse Events Scale Version 2.0, Functional Independence Measure Scale, European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 Scale and Visual Analogue Scale for pain before treatment and in 5 weeks of follow-up after treatment.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-16
• Study First Submitted QC: 2014-12-02
• Study First Posted: 2014-12-05
• Status Verified: 2015-11
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Last Update Submitted: 2015-11-11
• Last Update Posted: 2015-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Cancer adult patients with CIPN -

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Exclusion Criteria

Other neuropathy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture	Acupuncture	acupuncture
Acupuncture	Orientation group	acupuncture
orientation group	Orientation group	medical management guidelines for foot / hands care, sensory desensitization, risk prevention guidelines, proper ergonomics and orthoses when necessary.

Primary Outcome Measures

Name	Time	Method
neurological symptoms	up to 7 weeks	This study aims to determine the effectiveness of the use of acupuncture in relieving sensory and motor symptoms of patients with chemotherapy induced peripheral neuropathy

Secondary Outcome Measures

Name	Time	Method
functional impairment	up to 7 weeks	This study aims to determine the effectiveness of the use of acupuncture in relieving functional impairments of patients with chemotherapy induced peripheral neuropathy
quality of life	up to 7 weeks	This study aims to determine the influence of the use of acupuncture in quality of life of patients with chemotherapy induced peripheral neuropathy

Trial Locations

Locations (1)

Instituto do Cancer do Estado de São Paulo ICESP; 🇧🇷 São Paulo, SP, Brazil