Clinical trial · Observational
The Effect of Taxane Chemotherapy on Balance in Breast Cancer Patients
NCT02391818CI-TRIAL-00040274IPMR BalancecompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Distorted; Balance | — | UNRESOLVED | — |
| Neuropathy | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Breast Cancer Patients receiving ACT
- description
- Adraimycin/Cytoxan/Taxol
- label
- Breast Cancer patients receiving RT only
- description
- radiation therapy
Primary outcomes (1)
- measure
- Change from baseline Modified Clinical Test of Sensory Integration of Balance at 9 months.
- timeFrame
- An average of 5 months for the controls, and 9 months for the cases.
- description
- 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
Secondary outcomes (6)
- measure
- Change from baseline Five Times Sit to STand
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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.
References
Publications (9)
- BACKGROUNDWampler 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 17678662
- BACKGROUNDWinters-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 21367394
- BACKGROUNDTofthagen 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 21380613
- BACKGROUNDWhitney 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 16180952
- BACKGROUNDLord SR, Menz HB. Visual contributions to postural stability in older adults. Gerontology. 2000 Nov-Dec;46(6):306-10. doi: 10.1159/000022182. PMID 11044784
- BACKGROUNDShimozuma 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 19330359
- BACKGROUNDHausheer 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.