Distorted; BalanceIPMR BalanceNCT02391818
The Effect of Taxane Chemotherapy on Balance in Breast Cancer Patients
An observational study of Distorted; Balance and Quality of Life, run by OSF Healthcare System at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Distorted; Balance, Quality of Life, Neuropathy
- How many people
- 19 participants
- Where
- 4 sitesUnited States
- Study dates
- Feb 2015to 16 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients from cancer treatment clinic and radiation oncology clinics
Who may be able to join
- Women with breast cancer (stage 0-III)
- Scheduled to receive any of the following individual treatment protocols:
- ACT
- Radiation only
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Illinois CancerCare
Pekin, Illinois, 61554
OSF Radiation Oncology
Pekin, Illinois, 61554
Illinois CancerCare
Peoria, Illinois, 61615
OSF Radiation Oncology
Peoria, Illinois, 61615
About this study
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.
Read the 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
- Keywords
- balance, quality of life, chemotherapy, neuropathy, cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer Patients receiving ACT | Adraimycin/Cytoxan/Taxol | |
| Breast Cancer patients receiving RT only | radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Time in seconds it takes to stand up and sit down from a standard height chair
Measured: An average of 5 months for the controls, and 9 months for the cases.
Change from baseline Visual Contrast Sensitivity
Using the Mars Letter Chart, a contrast sensitivity score is calculated
Measured: An average of 5 months for the controls, and 9 months for the cases.
Change from baseline Touch Detection Threshold
The lightest Von Frey Filament able to be detected using the up/down method is recorded on 3 places of each foot
Measured: An average of 5 months for the controls, and 9 months for the cases.
Change from baseline Patient Neurotoxicity Questionnaire
Likert scale describing the level of intensity of lower extremity neuropathy symptoms and their interference with functional activities
Measured: An average of 5 months for the controls, and 9 months for the cases.
Change from baseline Patient Neuropathy Function Questionnaire
number of falls are recorded, as well as Likert scales for various functional activities
Measured: An average of 5 months for the controls, and 9 months for the cases.
Change from baseline Edmonton Symptom Assessment Scale
Quality of life scale validated for the breast cancer population
Measured: An average of 5 months for the controls, and 9 months for the cases.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completion16 Jun 2017
- Study completion16 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Distorted; BalanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- OSF Healthcare System
- Sponsor type
- University, hospital or other
- Collaborators
- Illinois CancerCare, P.C., University of Illinois College of Medicine at Peoria, St. Francis Hospitals & Health Centers
- Responsible party
- Principal investigator, Catherine Horst, OSF Healthcare System
- Investigators
- Carl Asche, PhD, Study director, University of Illinois College of Medicine at PeoriaJinma Ren, PhD, Study director, University of Illinois College of Medicine at PeoriaCatherine Horst, DPT, Principal investigator, IPMRNguyet Le-Lindqwister, MD, Study director, Illinois CancerCareAnthony Zalduendo, MD, Study director, OSF Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02391818
- Sponsor's protocol ID
- 599231-1
- Acronym
- IPMR Balance
- Status last verified
- Aug 2019
- First submitted
- 20 Feb 2015
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17678662Winters-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.
PubMed 21367394Tofthagen 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.
PubMed 21380613Whitney 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.
PubMed 16180952Lord SR, Menz HB. Visual contributions to postural stability in older adults. Gerontology. 2000 Nov-Dec;46(6):306-10. doi: 10.1159/000022182.
PubMed 11044784Shimozuma 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.
PubMed 19330359Hausheer 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.
PubMed 16473643Dougherty 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.
PubMed 16317373Mancini 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.
PubMed 20485226
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Taxane Chemotherapy on Balance in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT02391818
- Acronym / sponsor ID
- IPMR Balance / 599231-1
- Conditions
- Distorted; Balance, Quality of Life, Neuropathy, Cancer
- Keywords
- balance, quality of life, chemotherapy, neuropathy, cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- OSF Healthcare SystemUniversity, hospital or other
- Collaborators
- Illinois CancerCare, P.C., University of Illinois College of Medicine at Peoria, St. Francis Hospitals & Health Centers
- Study start
- Feb 2015
- Primary completion
- 16 Jun 2017 (actual)
- Study completion
- 16 Jun 2017 (actual)
- First posted
- 18 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer Patients receiving ACT | – | –Adraimycin/Cytoxan/Taxol |
| Breast Cancer patients receiving RT only | – | –radiation therapy |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients from cancer treatment clinic and radiation oncology clinics
Key inclusion criteria (4 listed)
- Women with breast cancer (stage 0-III)
- Scheduled to receive any of the following individual treatment protocols:
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from baseline Modified Clinical Test of Sensory Integration of Balance at 9 months.
Time frame: 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
6 secondary outcomes
Change from baseline Five Times Sit to STand
Time frame: An average of 5 months for the controls, and 9 months for the cases.
Change from baseline Visual Contrast Sensitivity
Time frame: An average of 5 months for the controls, and 9 months for the cases.
Change from baseline Touch Detection Threshold
Time frame: An average of 5 months for the controls, and 9 months for the cases.
Change from baseline Patient Neurotoxicity Questionnaire
Time frame: An average of 5 months for the controls, and 9 months for the cases.
Change from baseline Patient Neuropathy Function Questionnaire
Time frame: An average of 5 months for the controls, and 9 months for the cases.
Change from baseline Edmonton Symptom Assessment Scale
Time frame: An average of 5 months for the controls, and 9 months for the cases.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Background: PubMed 17678662Wampler 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.
- Background: PubMed 21367394Winters-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.
- Background: PubMed 21380613Tofthagen 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.
- Background: PubMed 16180952Whitney 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.
- Background: PubMed 11044784Lord SR, Menz HB. Visual contributions to postural stability in older adults. Gerontology. 2000 Nov-Dec;46(6):306-10. doi: 10.1159/000022182.
- Background: PubMed 19330359Shimozuma 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.
- Background: PubMed 16473643Hausheer 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.
- Background: PubMed 16317373Dougherty 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.
- Background: PubMed 20485226Mancini 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carl Asche, PhD study director
University of Illinois College of Medicine at Peoria
Jinma Ren, PhD study director
University of Illinois College of Medicine at Peoria
Catherine Horst, DPT principal investigator
IPMR
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Distorted; Balance and Quality of Life, run by OSF Healthcare System at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Modified Clinical Test of Sensory Integration of Balance at 9 months. (time frame: An average of 5 months for the controls, and 9 months for the cases.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02391818, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.