Pilot Study Investigating the Use of the ReBuilder to Tre... | NCT02606110

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

NCT02606110

Sponsor

Eastern Regional Medical Center

Status

Withdrawn

Last Update Posted

Jul 12, 2017Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Peripheral Neuropathy

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

PI decided no longer to pursue

Expanded Access Info

Start Date

Jun 2014

Primary Completion Date

Dec 2015Estimated

Completion Date

Not provided

First Submitted Date

May 26, 2015

First Submission Date that Met QC Criteria

Nov 13, 2015

First Posted Date

Nov 17, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 10, 2017

Last Update Posted Date

Jul 12, 2017Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with breast cancer and chemotherapy induced peripheral neuropathy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Eastern Regional Medical Center		Philadelphia	Pennsylvania	19124	United States

Condition Browse Module

MeSH Terms

ID	Term
D010523	Peripheral Nervous System Diseases
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided