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JOURNAL ONKOLOGIE – STUDIE

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

Rekrutierend

NCT-Nummer:
NCT04692168

Studienbeginn:
Oktober 2020

Letztes Update:
11.01.2021

Wirkstoff:
-

Indikation (Clinical Trials):
Breast Neoplasms

Geschlecht:
Frauen

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Aline Reinmann

Collaborator:
-

Studienleiter

Aline Reinmann
Principal Investigator
School of Health Sciences Geneva

Kontakt

Studienlocations (1 von 1)

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

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:

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.

Quelle: ClinicalTrials.gov


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