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

Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02309164
• Other study ID #: 261/14
• Status: Completed
• Phase: N/A
• First received: September 16, 2014
• Last updated: November 11, 2015
• Start date: September 2014
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Cancer adult patients with CIPN -

Exclusion Criteria:

Other neuropathy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adult Disease
• Neoplasm
• Neuropathy
• Peripheral Nervous System Diseases

Intervention

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.

Locations

Country	Name	City	State
Brazil	Instituto do Cancer do Estado de São Paulo ICESP	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No