Peripheral NeuropathyNCT02606110
Pilot Study Investigating the Use of the ReBuilder to Treat Chemotherapy Induced Peripheral Neuropathy in Patients With Breast Cancer
An observational study of Peripheral Neuropathy, run by Eastern Regional Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Neuropathy
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with breast cancer and chemotherapy induced peripheral neuropathy
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Eastern Regional Medical Center
Philadelphia, Pennsylvania, 19124
About this study
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.
- Conditions
- Peripheral Neuropathy
- Keywords
- ReBuilder, breast cancer, chemotherapy induced
- Medical subject headings
- Peripheral Nervous System Diseases, Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in touch and sensory by way of change in the Semmes-Weinstein Monofilament Testing
Measured: one year
Changes in touch and sensory by way of changes in Functional Gait Assessment
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2015 (estimated)
- Study startJun 2014
- Primary completionDec 2015 (estimated)
Why it stopped: PI decided no longer to pursue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Regional Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02606110
- Sponsor's protocol ID
- ERMC 14-11
- Status last verified
- Jul 2017
- First submitted
- 26 May 2015
- Last updated
- 12 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Investigating the Use of the ReBuilder to Treat Chemotherapy Induced Peripheral Neuropathy in Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT02606110
- Acronym / sponsor ID
- ERMC 14-11
- Conditions
- Peripheral Neuropathy
- Keywords
- ReBuilder, breast cancer, chemotherapy induced
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI decided no longer to pursue
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Eastern Regional Medical CenterUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2015 (estimated)
- First posted
- 17 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with breast cancer and chemotherapy induced peripheral neuropathy
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in touch and sensory by way of change in the Semmes-Weinstein Monofilament Testing
Time frame: one year
Changes in touch and sensory by way of changes in Functional Gait Assessment
Time frame: One year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Neuropathy, run by Eastern Regional Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in touch and sensory by way of change in the Semmes-Weinstein Monofilament Testing (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2017.