- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04692168
Influence of Chemotherapy on Postural Control in Women With Cancer
May 4, 2023 updated by: Aline Reinmann
Influence of Chemotherapy on Postural Control and Quality of Life in Women With Gynaecological Cancer: a Prospective Observational Study
The aim of this study is to understand the strategies for adapting postural control in patients who have received chemotherapy treatment for gynaecological cancer.
Study Overview
Status
Completed
Conditions
Detailed Description
Chemotherapy can cause many side effects, including peripheral neuropathies.
Chemotherapy induced peripheral neuropathies (CIPN) are primarily sensory impairments that can alter the signals for somatosensory feedback and thus affect the postural control in the standing position.
The objective of this study is to evaluate the impact of chemotherapy and peripheral neuropathies on postural control in the standing position.
As balance maintenance is a complex construct involving different systems, this study will evaluate maintenance strategies during sensory disturbances in order to better understand post-chemotherapy coping strategies.
These sensory disturbances concern vision (eyes closed) and the alteration of the somatosensory system (foam under the feet and vibration system).
In addition, this study will evaluate balance in double task situations and dynamic stability.
Given the consequent impact of chemotherapy and peripheral neuropathies on quality of life, a quality of life questionnaire will also be administered.
Study Type
Observational
Enrollment (Actual)
35
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Geneva, Switzerland, 1205
- Geneva University Hospitals
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
The study population will consist of 31 women between the ages of 18 and 65 consulting at the University Hospitals for their oncological disease.
Description
Inclusion Criteria:
Women
- between 18 and 65 years;
- with a gynaecological cancer about to start chemotherapy known to be neurotoxic (paclitaxel, docetaxel, nab-paclitaxel, or paclitaxel-carboplatin);
- able to stand upright for 30 s on a flat surface without assistance;
- able to provide written consent
Exclusion Criteria:
Women
- with pre-existing vestibular, uncorrectable visual, or somatosensory disorders or other pathologies altering postural control that would influence testing;
- with exposure to known neurotoxic chemotherapy (paclitaxel, docetaxel, nab-paclitaxel, vinorelbine, trastuzumab-emtansine, eribulin, or paclitaxel-carboplatin) that may have caused previous CIPN;
- with an inability to perform the test due to poor comprehension of instructions or psychological problems.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Entire group
The group will be test prior and three months after a neurotoxic chemotherapy for gynecological cancer.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline : postural control under various conditions.
Time Frame: Prior and three months after chemotherapy
|
The postural control will be assessed by a force platform.
Three 30-second tests will be performed for each test condition.
The test conditions are as follows: eyes open, eyes closed, firm surface, soft surface, with vibrator, without vibrator, with dual task.
The test position will be standing with the feet 10 cm apart at heel level and 15 cm apart at hallux level, with the arms along the body, fixing a point on the wall at 0.90 cm.
Parameters of center of pressure and strength will be recorded at a frequency of 100 Hertz.
|
Prior and three months after chemotherapy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline : modifications of postural control according to the conditions tested.
Time Frame: Prior and three months after chemotherapy
|
The postural control will be assessed by a force platform.
Three 30-second tests will be performed for each test condition.
The test conditions are as follows: eyes open, eyes closed, firm surface, soft surface, with vibrator, without vibrator, with dual task.
The test position will be standing with the feet 10 cm apart at heel level and 15 cm apart at hallux level, with the arms along the body, fixing a point on the wall at 0.90 cm.
Parameters of center of pressure and strength will be recorded at a frequency of 100 Hertz.
|
Prior and three months after chemotherapy
|
Change from baseline : standing dynamic stability.
Time Frame: Prior and three months after chemotherapy
|
The standing dynamic stability will be assessed by a force platform with the limits of stability test (LOS).
The test position will be standing with the feet 10 cm apart at heel level and 15 cm apart at hallux level, with the arms along the body, fixing a computer at a distance of 0.90 cm.
Parameters of center of pressure and strength will be recorded at a frequency of 100 Hertz.
|
Prior and three months after chemotherapy
|
Change from baseline : quality of life assessed by the questionnaire Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX).
Time Frame: Prior and three months after chemotherapy
|
The FACT/GOG-NTX was chosen to assess the quality of life (QoL).
This questionnaire assesses physical well-being, family/social well-being, emotional well-being, functional well-being and other concern.
Participants will have to answer the different statements by ticking the box corresponding to what they feel is adequate between 0 (not at all) and 4 (a lot).
The minimum score is 0 and the maximum score is 152.
The higher the score, the better the QoL.
|
Prior and three months after chemotherapy
|
Change from baseline : investigate the association between the severity of CIPN (mild, moderate, severe) and the postural control, dynamic balance and QoL of individuals with gynaecological cancer.
Time Frame: Prior and three months after chemotherapy
|
The clinical version of the Total Neuropathy Score will be used to evaluate the presence of peripheral neuropathy.
A test of superficial sensitivity, vibration sensitivity, reflexes and strength will be carried out.
The minimum score is 0 and the maximum score is 24.
A score between 0 and 8 indicates mild peripheral neuropathy, between 9 and 16 a moderate peripheral neuropathy and above 17 a severe neuropathy.
|
Prior and three months after chemotherapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Aline Reinmann, School of Health Sciences Geneva
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kneis S, Wehrle A, Freyler K, Lehmann K, Rudolphi B, Hildenbrand B, Bartsch HH, Bertz H, Gollhofer A, Ritzmann R. Balance impairments and neuromuscular changes in breast cancer patients with chemotherapy-induced peripheral neuropathy. Clin Neurophysiol. 2016 Feb;127(2):1481-1490. doi: 10.1016/j.clinph.2015.07.022. Epub 2015 Aug 14.
- McCrary JM, Goldstein D, Trinh T, Timmins HC, Li T, Menant J, Friedlander M, Lewis CR, Hertzberg M, O'Neill S, King T, Bosco A, Harrison M, Park SB. Balance Deficits and Functional Disability in Cancer Survivors Exposed to Neurotoxic Cancer Treatments. J Natl Compr Canc Netw. 2019 Aug 1;17(8):949-955. doi: 10.6004/jnccn.2019.7290.
- Monfort SM, Pan X, Loprinzi CL, Lustberg MB, Chaudhari AMW. Impaired Postural Control and Altered Sensory Organization During Quiet Stance Following Neurotoxic Chemotherapy: A Preliminary Study. Integr Cancer Ther. 2019 Jan-Dec;18:1534735419828823. doi: 10.1177/1534735419828823.
- Muller J, Ringhof S, Vollmer M, Jager LB, Stein T, Weiler M, Wiskemann J. Out of balance - Postural control in cancer patients before and after neurotoxic chemotherapy. Gait Posture. 2020 Mar;77:156-163. doi: 10.1016/j.gaitpost.2020.01.012. Epub 2020 Jan 15.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 7, 2020
Primary Completion (Actual)
December 31, 2022
Study Completion (Actual)
December 31, 2022
Study Registration Dates
First Submitted
December 28, 2020
First Submitted That Met QC Criteria
December 28, 2020
First Posted (Actual)
December 31, 2020
Study Record Updates
Last Update Posted (Estimate)
May 5, 2023
Last Update Submitted That Met QC Criteria
May 4, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 105909
- 2020-01639 (Registry Identifier: BASEC)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified individual participant data for all primary and secondary outcomes will be made available.
IPD Sharing Time Frame
Data will be available within 6 months of study completion
IPD Sharing Access Criteria
At the end of the project the data will be deposited in the Yareta repository developed by the University of Geneva OR in an institutional repository.
This choice will ensure that data is archived and shared in accordance with FAIR principles (Findability, Accessibility, Interoperability, and Reuse of digital assets).
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cancer, Breast
-
Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyActive, not recruitingStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonTerminatedBreast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIcUnited States
-
CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Susan G. Komen Breast Cancer FoundationCompletedStage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)WithdrawnStage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast Cancer