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

Not Applicable

Completed

• Conditions: Colorectal Cancer
• Interventions: Device: VibrosSense Meter®

• Registration Number: NCT03542136
• Lead Sponsor: Lund University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-17
• Study First Submitted QC: 2018-05-30
• Study First Posted: 2018-05-31
• Study Start: 2018-06-04
• Status Verified: 2020-08
• Primary Completion: 2020-11-30
• Study Completion: 2020-11-30
• Last Update Submitted: 2021-02-19
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients receiving chemotherapy treatment with oxaliplatin.	VibrosSense Meter®	-

Primary Outcome Measures

Name	Time	Method
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.	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.	Multi frequency tactilometry device is used.

Secondary Outcome Measures

Name	Time	Method
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).	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	Multi frequency tactilometry device is used.

Trial Locations

Locations (1)

Lund University Hospital; 🇸🇪 Lund, Sweden