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临床试验/NCT02391818
NCT02391818已完成不适用

The Effect of Taxane Chemotherapy on Balance in Breast Cancer Patients

OSF Healthcare System2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2015年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
19
试验地点
2
主要终点
Change from baseline Modified Clinical Test of Sensory Integration of Balance at 9 months.

研究概览

简要总结

The purpose of this study is to quantify the balance impairments during and after taxane chemotherapy. Disability due to balance impairments caused by chemotherapy induced peripheral neuropathy (CIPN) can cause falls, injury, and a decline in independence. This results in poor treatment outcomes such as greater morbidity and mortality, inability to complete treatment protocols, self-limitation of activity, and diminished quality of life.

详细描述

The purpose of this study is to describe the balance deficits prior to the initiation of taxane therapy and through the duration of treatment and compare balance to a cohort of women without taxane therapy. To our knowledge, a study like this has not been done yet it is a necessary next step in order to evaluate whether balance deficits resolve independent of treatment or if the balance deficits require targeted therapy. Other studies evaluating balance in taxane patients, have used cross-sectional study designs that are limited to observation at one point in time. Further, other evaluations have been limited in the measurement of balance using only self-report questionnaires, with no performance measurements of functional balance. Previous studies of other conditions have shown poor concordance between self-report questionnaires and performance measures. Therefore, our proposed longitudinal study improves the current knowledge about balance deficits during taxane therapy by quantifying the impact of taxane chemotherapy on balance during and after treatment using standardized and validated self-report and performance functional balance assessment tools. The results of this study will improve the treatment of balance deficits in women with taxane therapy by identifying the type, onset, duration, and severity of the deficits within each balance system. From these findings, targeted interventions, if required, could be developed. In addition, establishing feasibility and utility for quantifying balance impairments is necessary for the development of larger studies assessing the effects of rehabilitation interventions on functional disability due to CIPN. Such a study would be worthy of influencing changes in clinical practice to minimize disability from balance dysfunction before, during, and after chemotherapy, and thus maximizing function and quality of life during and after cancer treatment.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • Women with breast cancer (stage 0-III)
  • Scheduled to receive any of the following individual treatment protocols:
  • Radiation only

排除标准

  • Required assistive device for ambulation in the 6 months prior to starting treatment
  • Previous taxane or platinum chemotherapy (paclitaxel/Taxol®, docetaxel/Taxotere®, cabazitaxel/Jevtana®, cisplatin, carboplatin, and oxaliplatin)
  • Inability to stand or walk without assistance
  • BMI >40 (see chart below)
  • Pre-existing vestibular, visual, somatosensory, orthopedic, and neurologic disease before entering the study including but not limited to being legally blind (ICD9 368.3, 369.0-369.2 lower extremity amputation (ICD9 895.0-897.7), and Diabetes (ICD9 249.0-250.93, 257.2)
  • Evidence of central nervous system metastasis
  • Cognitive difficulties or medical conditions that, in the opinion of the study investigators, will affect testing protocols
  • Enrollment in other trial aimed at treating CIPN.

结局指标

主要结局

Change from baseline Modified Clinical Test of Sensory Integration of Balance at 9 months.

时间窗: An average of 5 months for the controls, and 9 months for the cases.

assessment of static balance under conditions eyes open on firm surface, eyes closed on firm surface, eyes open on foam surface, and eyes closed on foam surface

次要结局

  • Change from baseline Five Times Sit to STand(An average of 5 months for the controls, and 9 months for the cases.)
  • Change from baseline Touch Detection Threshold(An average of 5 months for the controls, and 9 months for the cases.)
  • Change from baseline Patient Neurotoxicity Questionnaire(An average of 5 months for the controls, and 9 months for the cases.)
  • Change from baseline Visual Contrast Sensitivity(An average of 5 months for the controls, and 9 months for the cases.)
  • Change from baseline Patient Neuropathy Function Questionnaire(An average of 5 months for the controls, and 9 months for the cases.)
  • Change from baseline Edmonton Symptom Assessment Scale(An average of 5 months for the controls, and 9 months for the cases.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Catherine Horst

Principle Investigator, Physical Therapist

OSF Healthcare System

研究点 (2)

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