Influence of Chemotherapy on Postural Control in Women With Cancer

Completed

• Conditions: Cancer, Gynecologic; Cancer, Breast

• Registration Number: NCT04692168
• Lead Sponsor: Aline Reinmann

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.

Study Timeline

• Study Start: 2020-10-07
• Study First Submitted: 2020-12-28
• Study First Submitted QC: 2020-12-28
• Study First Posted: 2020-12-31
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-04
• Last Update Posted: 2023-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 35

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline : postural control under various conditions.	Prior and three months after chemotherapy	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.

Secondary Outcome Measures

Name	Time	Method
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	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.
Change from baseline : modifications of postural control according to the conditions tested.	Prior and three months after chemotherapy	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.
Change from baseline : standing dynamic stability.	Prior and three months after chemotherapy	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.
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	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.

Trial Locations

Locations (1)

Geneva University Hospitals; 🇨🇭 Geneva, Switzerland