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

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Polyneuropathies Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lund University Hospital

Lund, 221 85, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VibrosSense Meter®

Device

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.

Primary outcomes

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.

Time frame: 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 outcomes

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).

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Lund University Hospital

Other

Registry information

Acronym: PENCOLA

Important dates

Study start: 2018
Primary completion: 2020
Study completion: 2020
First posted: May 31, 2018
Registry last updated: Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed