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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Neoplasm, Adult Disease, Neuropathy

Intervention / Treatment
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* Procedure: Acupuncture
* Behavioral: Orientation group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cancer adult patients with CIPN - Exclusion Criteria: Other neuropathy -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acupuncture<br>acupuncture | Procedure: Acupuncture<br>* 10 acupuncture sessions of 30 minutes each, twice a week<br>Behavioral: Orientation group<br>* medical management guidelines for foot / hands care, sensory desensitization, risk prevention guidelines, proper ergonomics and orthoses when necessary.<br>|
| Sham Comparator: orientation group<br>medical management guidelines for foot / hands care, sensory desensitization, risk prevention guidelines, proper ergonomics and orthoses when necessary. | Behavioral: Orientation group<br>* medical management guidelines for foot / hands care, sensory desensitization, risk prevention guidelines, proper ergonomics and orthoses when necessary.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neurological symptoms | 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 | up to 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functional impairment | This study aims to determine the effectiveness of the use of acupuncture in relieving functional impairments of patients with chemotherapy induced peripheral neuropathy | up to 7 weeks | 
| quality of life | This study aims to determine the influence of the use of acupuncture in quality of life of patients with chemotherapy induced peripheral neuropathy | up to 7 weeks |