Influence of Chemotherapy on Postural Control in Women With Cancer

NCT ID: NCT04692168

Last Updated: 2023-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-07

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Cancer, Breast Cancer, Gynecologic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Entire group

The group will be test prior and three months after a neurotoxic chemotherapy for gynecological cancer.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Aline Reinmann

OTHER

Sponsor Role lead

Responsible Party

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Aline Reinmann

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Aline Reinmann

Role: PRINCIPAL_INVESTIGATOR

School of Health Sciences Geneva

Locations

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Geneva University Hospitals

Geneva, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type BACKGROUND
PMID: 26350407 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31390588 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30741022 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32036320 (View on PubMed)

Reinmann A, Bodmer A, Koessler T, Gligorov J, Bruyneel AV. Postural control impairments following neurotoxic chemotherapy in women with cancer: a prospective observational study. BMC Womens Health. 2025 May 30;25(1):269. doi: 10.1186/s12905-025-03790-4.

Reference Type DERIVED
PMID: 40448057 (View on PubMed)

Reinmann A, Bruyneel AV, Gligorov J, Mesure S, Combescure C, Koessler T, Bodmer A. Influence of chemotherapy on postural control and quality of life in women with gynaecological cancer: a protocol of a prospective observational study. BMJ Open. 2022 Sep 7;12(9):e061664. doi: 10.1136/bmjopen-2022-061664.

Reference Type DERIVED
PMID: 36691184 (View on PubMed)

Other Identifiers

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2020-01639

Identifier Type: REGISTRY

Identifier Source: secondary_id

105909

Identifier Type: -

Identifier Source: org_study_id

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