NCT02606110

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2015

Completed
6 months until next milestone

First Posted

Study publicly available on registry

November 17, 2015

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Last Updated

July 12, 2017

Status Verified

July 1, 2017

Enrollment Period

1.5 years

First QC Date

May 26, 2015

Last Update Submit

July 10, 2017

Conditions

Peripheral Neuropathy

Keywords

ReBuilderbreast cancerchemotherapy induced

Outcome Measures

Primary Outcomes (2)

  • Changes in touch and sensory by way of change in the Semmes-Weinstein Monofilament Testing

    one year

  • Changes in touch and sensory by way of changes in Functional Gait Assessment

    One year

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with breast cancer and chemotherapy induced peripheral neuropathy

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Regional Medical Center

Philadelphia, Pennsylvania, 19124, United States

Location

MeSH Terms

Conditions

Peripheral Nervous System DiseasesBreast Neoplasms

Condition Hierarchy (Ancestors)

Neuromuscular DiseasesNervous System DiseasesNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2015

First Posted

November 17, 2015

Study Start

June 1, 2014

Primary Completion

December 1, 2015

Last Updated

July 12, 2017

Record last verified: 2017-07

Locations

US(1)