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

NCT ID: NCT02309164

Last Updated: 2015-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-11-30

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.

Conditions

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Neoplasm Adult Disease Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Acupuncture

acupuncture

Group Type ACTIVE_COMPARATOR

Acupuncture

Intervention Type PROCEDURE

10 acupuncture sessions of 30 minutes each, twice a week

Orientation group

Intervention Type BEHAVIORAL

medical management guidelines for foot / hands care, sensory desensitization, risk prevention guidelines, proper ergonomics and orthoses when necessary.

orientation group

medical management guidelines for foot / hands care, sensory desensitization, risk prevention guidelines, proper ergonomics and orthoses when necessary.

Group Type SHAM_COMPARATOR

Orientation group

Intervention Type BEHAVIORAL

medical management guidelines for foot / hands care, sensory desensitization, risk prevention guidelines, proper ergonomics and orthoses when necessary.

Interventions

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Acupuncture

10 acupuncture sessions of 30 minutes each, twice a week

Intervention Type PROCEDURE

Orientation group

medical management guidelines for foot / hands care, sensory desensitization, risk prevention guidelines, proper ergonomics and orthoses when necessary.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Cancer adult patients with CIPN -

Exclusion Criteria

Other neuropathy

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Rebeca Boltes Cecatto

Rebeca Boltes Cecatto

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rebeca B Cecatto, PhD

Role: PRINCIPAL_INVESTIGATOR

Instituto do Cancer do Estado de São Paulo

Locations

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Instituto do Cancer do Estado de São Paulo ICESP

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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D'Alessandro EG, Nebuloni Nagy DR, de Brito CMM, Almeida EPM, Battistella LR, Cecatto RB. Acupuncture for chemotherapy-induced peripheral neuropathy: a randomised controlled pilot study. BMJ Support Palliat Care. 2022 Mar;12(1):64-72. doi: 10.1136/bmjspcare-2018-001542. Epub 2019 Jun 29.

Reference Type DERIVED
PMID: 31256014 (View on PubMed)

Other Identifiers

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261/14

Identifier Type: -

Identifier Source: org_study_id

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