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Effect of Chemotherapies on the Balance of Women With Gynecological Cancer (CIPN)

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ClinicalTrials.gov Identifier: NCT04692168
Recruitment Status : Recruiting
First Posted : December 31, 2020
Last Update Posted : January 11, 2021
Sponsor:
Information provided by (Responsible Party):
Aline Reinmann, School of Health Sciences Geneva

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

Condition or disease
Cancer, Breast Cancer, Gynecologic

Detailed Description:
Chemotherapy can cause many side effects, including peripheral neuropathies. Peripheral neuropathies are primarily sensory impairments that can alter the signals for somatosensory feedback and thus affect the control of balance in the standing position. The objective of this study is to evaluate the impact of chemotherapy and peripheral neuropathies on static balance 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 balance. Given the consequent impact of chemotherapy and peripheral neuropathies on quality of life, a quality of life questionnaire will also be administered.

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Study Type : Observational
Estimated Enrollment : 31 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Chemotherapy and Chemotherapy-induced Peripheral Neuropathies on Static Balance, Dynamic Balance and Quality of Life in Women With Gynecologic Cancer: a Prospective Observational Study
Actual Study Start Date : October 7, 2020
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Change from baseline : Static upright balance [ Time Frame: Prior and three months after chemotherapy ]
    The static upright balance 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 100Hz.


Secondary Outcome Measures :
  1. Change from baseline : Dynamic upright balance [ Time Frame: Prior and three months after chemotherapy ]
    The static upright balance 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 100Hz.

  2. Change from baseline : score at the Total Neuropathy Score for the presence of peripheral neuropathy [ 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.

  3. Change from baseline : Quality of life assessed by the questionnaire FACT/GOG-NTX [ Time Frame: Prior and three months after chemotherapy ]
    The FACT/GOG-NTX was chosen to assess the quality of life. 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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study population will consist of 31 women between the ages of 18 and 60 consulting at the University Hospitals for their oncological disease.
Criteria

Inclusion Criteria:

  • Being a woman
  • Having an oncological disease
  • Being about to start chemotherapy within the next month known to be neurotoxic: paclitaxel, docetaxel, nab-paclitaxel, vinorelbine, trastuzumab-emtansine, eribulin, carboplatin.
  • Be able to give written consent
  • Be over 18 years of age (>18 years) and under 60 years of age
  • Be able to walk or stand upright for 30 seconds on a flat surface without any aids.

Exclusion Criteria:

  • Pre-existing vestibular, visual, uncorrectable, somatosensory disorders
  • Pre-existing pathologies that can alter postural balance (diabetes, cerebral metastasis, etc.).
  • Exposure to known chemotherapy that may cause peripheral neuropathies in the past.
  • Begin a balance-oriented activity (yoga, tai chi, physiotherapy, etc.) during the 12 week assessment.
  • Inability to carry out the test due to lack of understanding of instructions or psychological problems.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04692168


Contacts
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Contact: Aline Reinmann 22 388 35 85 ext 0041 aline.reinmann@hesge.ch

Locations
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Switzerland
Geneva University Hospitals Recruiting
Geneva, Switzerland, 1205
Contact: Aline Reinmann    22 388 35 85 ext 0041    aline.reinmann@hesge.ch   
Sponsors and Collaborators
Aline Reinmann
Investigators
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Principal Investigator: Aline Reinmann School of Health Sciences Geneva
Publications:
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Responsible Party: Aline Reinmann, Principal Investigator, School of Health Sciences Geneva
ClinicalTrials.gov Identifier: NCT04692168    
Other Study ID Numbers: 105909
2020-01639 ( Registry Identifier: BASEC )
First Posted: December 31, 2020    Key Record Dates
Last Update Posted: January 11, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcomes will be made available.
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aline Reinmann, School of Health Sciences Geneva:
balance
chemotherapy induced peripheral neuropathy
quality of life
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases