Expired Study
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Columbus, Ohio 43210


Purpose:

Longitudinal Evaluation of Taxane induced neuropathy in early stage breast cancer.


Study summary:

A study assessing the feasibility of evaluating neuropathy symptoms prospectively using testing of gate and balance parameters.


Criteria:

Inclusion criteria - Patients (men and women) diagnosed with breast cancer stages I-III initiating first line adjuvant or neoadjuvant therapy with paclitaxel or docetaxel - Ability to understand and the willingness to sign a written informed consent document. - Patients with functional limitations due to musculoskeletal conditions can be included, because these conditions are known to remain stable over the relatively short duration of the study. - Concurrent standard and investigational agents are permissible with the standard chemotherapy drugs. Exclusion Criteria - Prior known chemotherapy or targeted therapy (for breast cancer or other malignancies that is known to be associated with neuropathy in the last 12 months(platinum therapy, bortezomib, vinblastine, etc.) - Prior taxane exposure at any time - Preexisting known diagnosis of any type of neuropathy prior to start of paclitaxel or docetaxel chemotherapy - Pregnant or nursing women. - Unable to give informed consent. - Preexisting lower extremity amputation - Inability to walk or stand without assistance due to any condition - Neuropathic pain medications prior to start of study including gabapentin, pregabalin, amytriptyline, and duloxetine (but initiation of neuropathic pain medications during treatment are permissible) - Patients needing ambulatory assist devices - Back or lower extremity surgery in the last 6 months - Back or lower extremity surgery at any timepoint that interferes with gait and balance per patient or provider report


Study is Available At:


Original ID:

OSU-13010


NCT ID:

NCT02125019


Secondary ID:


Study Acronym:


Brief Title:

Longitudinal Evaluation of Taxane Induced Neuropathy in Early Stage Breast Cancer


Official Title:

Longitudinal Evaluation of Taxane Induced Neuropathy in Early Stage Breast Cancer


Overall Status:

Active, not recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Ohio State University Comprehensive Cancer Center


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

62


Enrollment Type:

Actual


Overall Contact Information

Official Name:Maryam Lustberg, MD, MPH
Principal Investigator
Ohio State University Comprehensive Cancer Center

Study Dates

Start Date:September 25, 2013
Completion Date:December 31, 2019
Completion Type:Anticipated
Primary Completion Date:December 31, 2019
Primary Completion Type:Anticipated
Verification Date:May 2019
Last Changed Date:May 20, 2019
First Received Date:April 23, 2014

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Identify gait and balance changes as a consequence of chemotherapy with paclitaxel or docetaxel in the laboratory measuring the motion of the entire body in three dimensions with great accuracy.
Time Frame:Up to 2 years
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Evaluate the natural history of changes in these gait and balance parameters and their relationships with validated self-reported assessment tools of CIPN such as CIPN-20 and TNS
Time Frame:Up to 2 years
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Identify gait and balance parameters that are affected by during adjuvant/neoadjuvant taxane (paclitaxel or docetaxel) chemotherapy.
Time Frame:Up to 2 years
Safety Issues:False

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:Breast cancer patients
Description:This is a single arm study evaluating feasibility of evaluating gait and parameter changes in patients with early stage breast cancer undergoing adjuvant taxane chemotherapy.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Ohio State University Comprehensive Cancer Center

Samples and Retentions

Study Population: Men and women diagnosed with breast cancer stages I-III
Sample Method:Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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