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NCT02606110 Clinical Trial

Pilot Study Investigating the Use of the ReBuilder to Treat Chemotherapy Induced Peripheral Neuropathy in Patients With Breast Cancer

Peripheral Neuropathy Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02606110
Other study ID # ERMC 14-11
Secondary ID
Status Withdrawn
Phase N/A
First received May 26, 2015
Last updated July 10, 2017
Start date June 2014

Study information
Verified date July 2017
Source Eastern Regional Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to investigate the effect of the ReBuilder in the treatment of individuals with breast cancer and chemotherapy induced peripheral neuropathy.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date December 2015
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients with breast cancer referred to Physical Therapy for CIPN

- Physical Therapy Examination indicates use of Rebuilder for CIPN

- At least 18 years of age

- Signed informed consent for study population

- Willingness to complete study according to protocol

Exclusion Criteria:

- Patients who do not have CIPN

- Patients <18 years of age

- Inability to or unwilling to sign informed consent

- Unable to read and understand the English language

- Preexisting sensory peripheral neuropathy from other comorbid conditions such as diabetes or alcoholism

- More than three (3) prior ReBuilder treatments; OR ReBuilder within the last 30 days, for sensory peripheral neuropathy

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Eastern Regional Medical Center Philadelphia Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Eastern Regional Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in touch and sensory by way of change in the Semmes-Weinstein Monofilament Testing one year
Primary Changes in touch and sensory by way of changes in Functional Gait Assessment One year
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