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

Sponsor

University of Sao Paulo (Other)

Overall Status

Completed

CT.gov ID

NCT02309164

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Neoplasm Adult Disease Neuropathy	Procedure: Acupuncture Behavioral: Orientation group	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2014

Actual Primary Completion Date :

Nov 1, 2015

Actual Study Completion Date :

Nov 1, 2015

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Acupuncture

acupuncture

Procedure: Acupuncture

10 acupuncture sessions of 30 minutes each, twice a week

Behavioral: Orientation group

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

Sham Comparator: orientation group

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

Behavioral: Orientation group

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Cancer adult patients with CIPN -

Exclusion Criteria:

Other neuropathy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Instituto do Cancer do Estado de São Paulo ICESP	São Paulo	SP	Brazil	01246 000

Sponsors and Collaborators

University of Sao Paulo

Investigators

Principal Investigator: Rebeca B Cecatto, PhD, Instituto do Cancer do Estado de São Paulo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rebeca Boltes Cecatto, Rebeca Boltes Cecatto, University of Sao Paulo

ClinicalTrials.gov Identifier:

NCT02309164

Other Study ID Numbers:

261/14

First Posted:

Dec 5, 2014

Last Update Posted:

Nov 13, 2015

Last Verified:

Nov 1, 2015

Additional relevant MeSH terms:

Peripheral Nervous System Diseases

Study Results

No Results Posted as of Nov 13, 2015