An observational study in Cancer, Breast and Cancer, Gynecologic, sponsored by Aline Reinmann. Completed at 1 site in Switzerland. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-05-06.
Sponsored by Aline Reinmann · Observational
The aim of this study is to understand the strategies for adapting postural control in patients who have received chemotherapy treatment for gynaecological cancer.
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.
12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 35 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
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The study population will consist of 31 women between the ages of 18 and 65 consulting at the University Hospitals for their oncological disease.
Women
Exclusion Criteria:
Women
The group will be test prior and three months after a neurotoxic chemotherapy for gynecological cancer.
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.
Time frame: Prior and three months after chemotherapy
Change from baseline : modifications of postural control according to the conditions tested.
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.
Time frame: Prior and three months after chemotherapy
Change from baseline : standing dynamic stability.
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.
Time frame: 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).
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.
Time frame: 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.
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.
Time frame: Prior and three months after chemotherapy
Plan to share: Yes — De-identified individual participant data for all primary and secondary outcomes will be made available.
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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