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

NCT03542136 | Completed

• 1 other identifier: MKM-1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

Polyneuropathy; Oxaliplatin; Colorectal cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

Patients receiving chemotherapy treatment with oxaliplatin.

OTHER

Device: VibrosSense Meter®

Interventions

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.

Patients receiving chemotherapy treatment with oxaliplatin.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lund University Hospital: lead

Study Sites (1)

Lund University Hospital

Lund, 221 85, Sweden

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Polyneuropathies

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2018
• First Posted: May 31, 2018
• Study Start: June 4, 2018
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: February 21, 2021

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share

Locations

SE (1)