Peripheral Neuropathy in Colorectal Cancer Patients Under Adjuvant Chemotherapy With FOLFOX, FLOX or XELOX Regime

Study Overview
=================
Brief Summary
-----------------
Oxaliplatin is a cytotoxic platinum compound and is one of the chemotherapeutic agent used in advanced colorectal cancer. It is used combined with Fluorouracil (5 FU) and Leucovorin. The main and most suffering side effect of oxaliplatin is polyneuropathy. Oxaliplatin-induced polyneuropathy (OIPN) can be acute and/or chronic neurotoxicity. 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.

Official Title
-----------------
Peripheral Neuropathy in Colorectal Cancer Patients Under Adjuvant Chemotherapy With FOLFOX, FLOX or XELOX Regime

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Device: VibrosSense Meter®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years 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: Age < 18 years. The patient does not consent to the examination Polyneuropathy grade according to CTCAE before treatment start >2. Performance status according to WHO >1.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients receiving chemotherapy treatment with oxaliplatin.<br> | Device: VibrosSense Meter®<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of evaluating the vibrotactile sense using a multi frequency tactilometry, in patients hand and foot. This is by assessing the changes in the measurements of a multi frequency tactilometry device in between each two time points. | Multi frequency tactilometry device is used. | Investigation before cycle 1, 4, 6, 7, 8, 10, 12 and 6 months after last cycle (cycle 12), if cycle length is 2 weeks. If cycle length is 3 weeks, evaluation before cycle 1, 3, 4, 5, 6,7, 8, and 6 months after last cycle. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate if Oxaliplatin induced polyneuropathy can be earlier detected by using a multi frequency tactilometry compared with Common Terminology Criteria for Adverse Events scale (CTCAE). | Multi frequency tactilometry device is used. | Investigation before cycle 1, 4, 6, 7, 8, 10, 12 and after 6 months after last cycle (cycle 12), if cycle length is 2 weeks. If cycle length is 3 weeks, evaluation before cycle 1, 3, 4, 5, 6,7, 8, and 6 months after last cycle | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Polyneuropathy, Oxaliplatin, Colorectal cancer