Clinical trial NCT04692168: Influence of Chemotherapy on Postural Control in Women With Cancer
Official title: Influence of Chemotherapy on Postural Control and Quality of Life in Women With Gynaecological Cancer: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer, Breast
Cancer, Gynecologic
Keywords: postural control
balance
chemotherapy induced peripheral neuropathy
quality of life
Lead sponsor: School of Health Sciences Geneva
Sponsor class: OTHER
First posted: 2020-12-31
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: The aim of this study is to understand the strategies for adapting postural control in patients who have received chemotherapy treatment for gynaecological cancer.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline : postural control under various conditions.
timeFrame: Prior and three months after chemotherapy
Secondary outcomes:
measure: Change from baseline : modifications of postural control according to the conditions tested.
timeFrame: Prior and three months after chemotherapy
measure: Change from baseline : standing dynamic stability.
timeFrame: Prior and three months after chemotherapy
measure: Change from baseline : quality of life assessed by the questionnaire Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX).
timeFrame: Prior and three months after chemotherapy
measure: 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.
timeFrame: Prior and three months after chemotherapy
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospitals
Study officials:
affiliation: School of Health Sciences Geneva
name: Aline Reinmann
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.