Longitudinal Evaluation of Taxane Induced Neuropathy in Early Stage Breast Cancer

NCT02125019 | Completed

• 1 other identifier: OSU-13010
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Keywords

Breast Cancer; Taxane; Gait; Men; Women

Outcome Measures

Primary Outcomes (1)

• Identify gait and balance parameters that are affected by during adjuvant/neoadjuvant taxane (paclitaxel or docetaxel) chemotherapy.

  Up to 2 years

Secondary Outcomes (2)

• 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

  Up to 2 years

• 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.

  Up to 2 years

Study Arms (1)

Breast cancer patients

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Men and women diagnosed with breast cancer stages I-III

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Breast Neoplasms; Multiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Study Officials

• Nicole Williams, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 23, 2014
• First Posted: April 29, 2014
• Study Start: December 4, 2013
• Primary Completion: May 14, 2018
• Study Completion: May 14, 2018
• Last Updated: February 27, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)