The Effect of Taxane Chemotherapy on Balance in Breast Cancer Patients

NCT ID: NCT02391818

Last Updated: 2019-08-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 19 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2017-06-16

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.

Detailed Description

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.

Conditions

Distorted; Balance; Quality of Life; Neuropathy; Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Breast Cancer Patients receiving ACT

Adraimycin/Cytoxan/Taxol

No interventions assigned to this group

Breast Cancer patients receiving RT only

radiation therapy

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Women with breast cancer (stage 0-III)

2. Scheduled to receive any of the following individual treatment protocols:

1. ACT

2. Radiation only

Exclusion Criteria

1. Required assistive device for ambulation in the 6 months prior to starting treatment

2. Previous taxane or platinum chemotherapy (paclitaxel/Taxol®, docetaxel/Taxotere®, cabazitaxel/Jevtana®, cisplatin, carboplatin, and oxaliplatin)

3. Inability to stand or walk without assistance

4. BMI >40 (see chart below)

5. 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)

6. Evidence of central nervous system metastasis

7. Cognitive difficulties or medical conditions that, in the opinion of the study investigators, will affect testing protocols

8. Enrollment in other trial aimed at treating CIPN.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Illinois CancerCare, P.C.

OTHER

Sponsor Role: collaborator

University of Illinois College of Medicine at Peoria

OTHER

Sponsor Role: collaborator

St. Francis Hospitals & Health Centers

OTHER

Sponsor Role: collaborator

OSF Healthcare System

OTHER

Sponsor Role: lead

Responsible Party

Catherine Horst

Principle Investigator, Physical Therapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carl Asche, PhD

Role: STUDY_DIRECTOR

University of Illinois College of Medicine at Peoria

Jinma Ren, PhD

Role: STUDY_DIRECTOR

University of Illinois College of Medicine at Peoria

Catherine Horst, DPT

Role: PRINCIPAL_INVESTIGATOR

IPMR

Nguyet Le-Lindqwister, MD

Role: STUDY_DIRECTOR

Illinois CancerCare

Anthony Zalduendo, MD

Role: STUDY_DIRECTOR

OSF Radiation Oncology

Locations

Illinois CancerCare

Pekin, Illinois, United States

OSF Radiation Oncology

Pekin, Illinois, United States

Illinois CancerCare

Peoria, Illinois, United States

OSF Radiation Oncology

Peoria, Illinois, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 17678662 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21367394 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21380613 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16180952 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 11044784 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19330359 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16473643 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16317373 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20485226 (View on PubMed)

Other Identifiers

599231-1

Identifier Type: -

Identifier Source: org_study_id