Back to resultsThe Use of Acupuncture for Treatment of Chemotherapy-induced Peripheral Neuropathy (CIPN).
Primary Purpose
Neoplasm, Adult Disease, Neuropathy
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Acupuncture
Orientation group
Sponsored by
About this trial
This is an interventional treatment trial for Neoplasm
Eligibility Criteria
Inclusion Criteria:
Cancer adult patients with CIPN -
Exclusion Criteria:
Other neuropathy
-
Sites / Locations
- Instituto do Cancer do Estado de São Paulo ICESP
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Acupuncture
orientation group
Arm Description
acupuncture
medical management guidelines for foot / hands care, sensory desensitization, risk prevention guidelines, proper ergonomics and orthoses when necessary.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
Full Information
NCT ID
NCT02309164
First Posted
September 16, 2014
Last Updated
November 11, 2015
Sponsor
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT02309164
Brief Title
The Use of Acupuncture for Treatment of Chemotherapy-induced Peripheral Neuropathy (CIPN).
Official Title
The Use of Acupuncture for Treatment of Chemotherapy-induced Peripheral Neuropathy (CIPN).
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
Yes
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasm, Adult Disease, Neuropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture
Arm Type
Active Comparator
Arm Description
acupuncture
Arm Title
orientation group
Arm Type
Sham Comparator
Arm Description
medical management guidelines for foot / hands care, sensory desensitization, risk prevention guidelines, proper ergonomics and orthoses when necessary.
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Description
10 acupuncture sessions of 30 minutes each, twice a week
Intervention Type
Behavioral
Intervention Name(s)
Orientation group
Intervention Description
medical management guidelines for foot / hands care, sensory desensitization, risk prevention guidelines, proper ergonomics and orthoses when necessary.
Primary Outcome Measure Information:
Title
neurological symptoms
Description
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
Time Frame
up to 7 weeks
Secondary Outcome Measure Information:
Title
functional impairment
Description
This study aims to determine the effectiveness of the use of acupuncture in relieving functional impairments of patients with chemotherapy induced peripheral neuropathy
Time Frame
up to 7 weeks
Title
quality of life
Description
This study aims to determine the influence of the use of acupuncture in quality of life of patients with chemotherapy induced peripheral neuropathy
Time Frame
up to 7 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cancer adult patients with CIPN -
Exclusion Criteria:
Other neuropathy
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebeca B Cecatto, PhD
Organizational Affiliation
Instituto do Cancer do Estado de São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto do Cancer do Estado de São Paulo ICESP
City
São Paulo
State/Province
SP
ZIP/Postal Code
01246 000
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
31256014
Citation
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.
Results Reference
derived
Learn more about this trial
The Use of Acupuncture for Treatment of Chemotherapy-induced Peripheral Neuropathy (CIPN).
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