NCT02391818

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2015

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2015

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 18, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2017

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

2.4 years

First QC Date

February 20, 2015

Last Update Submit

August 26, 2019

Conditions

Distorted; BalanceQuality of LifeNeuropathyCancer

Keywords

balancequality of lifechemotherapyneuropathycancer

Outcome Measures

Primary Outcomes (1)

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

    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

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

Secondary Outcomes (6)

  • 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 Visual Contrast Sensitivity

    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 Patient Neuropathy Function Questionnaire

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

  • +1 more secondary outcomes

Study Arms (2)

Breast Cancer Patients receiving ACT

Adraimycin/Cytoxan/Taxol

Breast Cancer patients receiving RT only

radiation therapy

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients from cancer treatment clinic and radiation oncology clinics

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Illinois CancerCare

Pekin, Illinois, 61554, United States

Location

OSF Radiation Oncology

Pekin, Illinois, 61554, United States

Location

Illinois CancerCare

Peoria, Illinois, 61615, United States

Location

OSF Radiation Oncology

Peoria, Illinois, 61615, United States

Location

Related Publications (9)

  • Wampler MA, Topp KS, Miaskowski C, Byl NN, Rugo HS, Hamel K. Quantitative and clinical description of postural instability in women with breast cancer treated with taxane chemotherapy. Arch Phys Med Rehabil. 2007 Aug;88(8):1002-8. doi: 10.1016/j.apmr.2007.05.007.

    PMID: 17678662BACKGROUND

  • Winters-Stone KM, Torgrimson B, Horak F, Eisner A, Nail L, Leo MC, Chui S, Luoh SW. Identifying factors associated with falls in postmenopausal breast cancer survivors: a multi-disciplinary approach. Arch Phys Med Rehabil. 2011 Apr;92(4):646-52. doi: 10.1016/j.apmr.2010.10.039. Epub 2011 Mar 2.

    PMID: 21367394BACKGROUND

  • Tofthagen C, Overcash J, Kip K. Falls in persons with chemotherapy-induced peripheral neuropathy. Support Care Cancer. 2012 Mar;20(3):583-9. doi: 10.1007/s00520-011-1127-7. Epub 2011 Mar 5.

    PMID: 21380613BACKGROUND

  • Whitney SL, Wrisley DM, Marchetti GF, Gee MA, Redfern MS, Furman JM. Clinical measurement of sit-to-stand performance in people with balance disorders: validity of data for the Five-Times-Sit-to-Stand Test. Phys Ther. 2005 Oct;85(10):1034-45.

    PMID: 16180952BACKGROUND

  • Lord SR, Menz HB. Visual contributions to postural stability in older adults. Gerontology. 2000 Nov-Dec;46(6):306-10. doi: 10.1159/000022182.

    PMID: 11044784BACKGROUND

  • Shimozuma K, Ohashi Y, Takeuchi A, Aranishi T, Morita S, Kuroi K, Ohsumi S, Makino H, Mukai H, Katsumata N, Sunada Y, Watanabe T, Hausheer FH. Feasibility and validity of the Patient Neurotoxicity Questionnaire during taxane chemotherapy in a phase III randomized trial in patients with breast cancer: N-SAS BC 02. Support Care Cancer. 2009 Dec;17(12):1483-91. doi: 10.1007/s00520-009-0613-7. Epub 2009 Mar 28.

    PMID: 19330359BACKGROUND

  • Hausheer FH, Schilsky RL, Bain S, Berghorn EJ, Lieberman F. Diagnosis, management, and evaluation of chemotherapy-induced peripheral neuropathy. Semin Oncol. 2006 Feb;33(1):15-49. doi: 10.1053/j.seminoncol.2005.12.010.

    PMID: 16473643BACKGROUND

  • Dougherty BE, Flom RE, Bullimore MA. An evaluation of the Mars Letter Contrast Sensitivity Test. Optom Vis Sci. 2005 Nov;82(11):970-5. doi: 10.1097/01.opx.0000187844.27025.ea.

    PMID: 16317373BACKGROUND

  • Mancini M, Horak FB. The relevance of clinical balance assessment tools to differentiate balance deficits. Eur J Phys Rehabil Med. 2010 Jun;46(2):239-48.

    PMID: 20485226BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Carl Asche, PhD

    University of Illinois College of Medicine at Peoria

    STUDY DIRECTOR

  • Jinma Ren, PhD

    University of Illinois College of Medicine at Peoria

    STUDY DIRECTOR

  • Catherine Horst, DPT

    IPMR

    PRINCIPAL INVESTIGATOR

  • Nguyet Le-Lindqwister, MD

    Illinois CancerCare

    STUDY DIRECTOR

  • Anthony Zalduendo, MD

    OSF Radiation Oncology

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator, Physical Therapist

Study Record Dates

First Submitted

February 20, 2015

First Posted

March 18, 2015

Study Start

February 1, 2015

Primary Completion

June 16, 2017

Study Completion

June 16, 2017

Last Updated

August 28, 2019

Record last verified: 2019-08

Locations

US(4)