Peripheral Neuropathy in Colorectal Cancer Patients Under Adjuvant Chemotherapy With FOLFOX, FLOX or XELOX Regime
NCT ID: NCT03542136
Last Updated: 2021-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2018-06-04
2020-11-30
Brief Summary
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The early detection of the neurotoxicity and changing the medication dose and/or schedule can prevent its development. It has been used different neurotoxicity scales in grading OIPN. In this study the investigators try to investigate whether the evaluation of the vibrotactile perception VTP, by using a multi frequency tactilometry in a patients hand and foot is a good indicator and superior to the standard of care to detect the underlying OIPN in patients undergoing adjuvant chemotherapy treatment with FOLFOX, FLOX or XELOX regime.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Patients receiving chemotherapy treatment with oxaliplatin.
VibrosSense Meter®
A multi frequency tactilometry device to evaluate the vibrotactile sense to indicate the underlying (Oxaliplatin induced poly neuropathy) OIPN and then compare the results with the results of CTCAE (Common toxicity criteria of adverse events) assessment tool evaluation.
Interventions
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VibrosSense Meter®
A multi frequency tactilometry device to evaluate the vibrotactile sense to indicate the underlying (Oxaliplatin induced poly neuropathy) OIPN and then compare the results with the results of CTCAE (Common toxicity criteria of adverse events) assessment tool evaluation.
Eligibility Criteria
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Inclusion Criteria
* Signed written informed consent.
* Fulfils the indication of the treatment with 3-6 months oxaliplatin combined adjuvant chemotherapy.
* Polyneuropathy grade according to CTCAE before treatment start ≤ 2.
* Performance status according to WHO ≤ 1.
Exclusion Criteria
* The patient does not consent to the examination
* Polyneuropathy grade according to CTCAE before treatment start \>2.
* Performance status according to WHO \>1.
18 Years
ALL
No
Sponsors
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Lund University Hospital
OTHER
Responsible Party
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Locations
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Lund University Hospital
Lund, , Sweden
Countries
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Other Identifiers
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MKM-1
Identifier Type: -
Identifier Source: org_study_id
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