Clinical trial NCT02125019: Longitudinal Evaluation of Taxane Induced Neuropathy in Early Stage Breast Cancer
Official title: Longitudinal Evaluation of Taxane Induced Neuropathy in Early Stage Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Breast Cancer
Taxane
Gait
Men
Women
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2014-04-29
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Men and women diagnosed with breast cancer stages I-III

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

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

Eligibility 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

Primary outcomes:
measure: Identify gait and balance parameters that are affected by during adjuvant/neoadjuvant taxane (paclitaxel or docetaxel) chemotherapy.
timeFrame: Up to 2 years
Secondary outcomes:
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
timeFrame: Up to 2 years
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.
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Wexner Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Nicole Williams, MD
role: PRINCIPAL_INVESTIGATOR
References: