Influence of Chemotherapy on Postural Control in Women With Cancer

NCT04692168 | Completed

• 2 other identifiers: 1059092020-01639
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer, Breast; Cancer, Gynecologic

Keywords

postural control; balance; chemotherapy induced peripheral neuropathy; quality of life

Outcome Measures

Primary Outcomes (1)

• Change from baseline : postural control under various conditions.

  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 Outcomes (4)

• Change from baseline : modifications of postural control according to the conditions tested.

  Prior and three months after chemotherapy

• Change from baseline : standing dynamic stability.

  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).

  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.

  Prior and three months after chemotherapy

Study Arms (1)

Entire group

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aline Reinmann: lead

Study Sites (1)

Geneva University Hospitals

Geneva, 1205, Switzerland

Location

Related Publications (6)

• 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.

  PMID: 26350407 BACKGROUND

• 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.

  PMID: 31390588 BACKGROUND

• 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.

  PMID: 30741022 BACKGROUND

• 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.

  PMID: 32036320 BACKGROUND

• 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.

  PMID: 40448057 DERIVED

• 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.

  PMID: 36691184 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Aline Reinmann

  School of Health Sciences Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 28, 2020
• First Posted: December 31, 2020
• Study Start: October 7, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available within 6 months of study completion
• 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).

Locations

CH (1)