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Completed

NCT Number: NCT02169908

Analysis of Chronic Neuropathic Pain Markers in Patients Treated With Oxaliplatin

The role of oxidative stress in the development of oxaliplatin-induced peripheral neuropathy has been previously described in mice and in neuronal cell cultures (Massicot 2013); clinical manifestations and pathophysiological mechanisms potentially involved have also been described in humans (Andreas 2007) (Attal 2009).

The investigators team plans to conduct a translational clinicobiological research to explain the nature of the biochemical and molecular mechanisms of the development of oxaliplatin-induced painful neuropathy. To perform this project, the investigators propose to realize a pilot study in patients newly treated with oxaliplatin. This will be conducted in the oncology department of Paris Saint Joseph Hospital from May 2014 until the inclusion of 20 patients.

The main objective of this pilot study is to evaluate the occurrence of acute and chronic neuropathic pain occurring in patients newly treated with oxaliplatin. The characterization of this pain is based on validated tests (Cruccu 2010).

Moreover, the biochemical changes related to oxidative stress and those related to cellular lipid composition are characterized in these patients.

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Key information

Conditions

Digestive Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Gynecological Cancer Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patient newly traeted with oxaliplatin
  • Patient suffering from any type of cancer treated with oxaliplatin
  • Man or Woman over 18

Exclusion criteria

  • Patient with brain or leptomeningeal metastases
  • Patient previously treated with cisplatin
  • Patient addicted to alcohol
  • Diabetic patient with peripheral neurological disorders
  • Patient receiving calcium or magnesium salts intravenously
  • Patient suffering from peripheral neuropathy
  • Patient suffering from psychiatric disorders
  • Patient treated with at least one of the following drug: venlafaxine, carbamazepine, gabapentin, pregabalin, clomipramine, amitriptyline, imipramine, duloxetine.

Treatment and study plan

Thermotest

Device

von Frey hairs

Device

Primary outcomes

  1. Thermal thresholds

    Time frame: Three to six months

    Four thermal thresholds are assessed by a Thermotest (Somedic AB):

    • cold perception threshold
    • warm perception threshold
    • cold pain threshold
    • warm pain threshold

Secondary outcomes

  1. Tactile sensitivity

    Time frame: Three to six months

    Tactile sensitivity is assessed with von Frey hairs.

Other outcomes

  1. Characterization of pain neuropathy

    Time frame: Three to six months

    Neuropathic Pain Symptom Inventory (NPSI questionnaire) is used.

Sponsors and collaborators

Lead sponsor

Fondation Hôpital Saint-Joseph

Other

Registry information

Official study title

LIPIDOXA, a Pilot Study of Analysis of Chronic Neuropathic Pain Markers in Patients Treated With Oxaliplatin-based Regimen

Acronym: LIPIDOXA

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Jun 23, 2014
Registry last updated
Mar 10, 2016

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.

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