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

Lund University Hospital

Status

Completed

Conditions

Colorectal Cancer

Treatments

Device: VibrosSense Meter®

Study type

Interventional

Funder types

Other

Identifiers

NCT03542136

MKM-1

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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