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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02309164
Recruitment Status : Completed
First Posted : December 5, 2014
Last Update Posted : November 13, 2015
Sponsor:
Information provided by (Responsible Party):
Rebeca Boltes Cecatto, 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

Condition or disease Intervention/treatment Phase
Neoplasm Adult Disease Neuropathy Procedure: Acupuncture Behavioral: Orientation group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : September 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. neurological symptoms [ Time Frame: 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 :
  1. functional impairment [ Time Frame: 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

  2. quality of life [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Cancer adult patients with CIPN -

Exclusion Criteria:

Other neuropathy

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02309164


Locations
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Brazil
Instituto do Cancer do Estado de São Paulo ICESP
São Paulo, SP, Brazil, 01246 000
Sponsors and Collaborators
University of Sao Paulo
Investigators
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Principal Investigator: Rebeca B Cecatto, PhD Instituto do Cancer do Estado de São Paulo
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rebeca Boltes Cecatto, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02309164    
Other Study ID Numbers: 261/14
First Posted: December 5, 2014    Key Record Dates
Last Update Posted: November 13, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases