Prevention of Oxaliplatin-induced Nerve Damage in the Body's Extremities

Vejle Hospital120 enrolled

Overview

The purpose of this study is to examine the effect of supplementary polyunsaturated fatty acids on nerve damage in the body's extremitites of patients treated with oxaliplatin containing chemotherapy after surgery for colorectal cancer.

The primary objective of the present study is to examine if a high dosage of n-3 PUFA reduces the incidence and severity of chemotherapy-induced peripheral neuropathy (CIPN) 8 months after adjuvant oxaliplatin following surgery for high-risk colorectal cancer. An additional aim is to investigate whether n-3 PUFAs have an effect on nutritional status, cognition and mental status. Inflammatory mechanisms and biomarkers of CIPN in skin biopsies and in blood will be explored.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

120

Conditions

Peripheral Neuropathy Colorectal Cancer

Interventions

Fish oilDIETARY_SUPPLEMENT

Fish oil containing poly unsaturated fatty acids.

Corn oilDIETARY_SUPPLEMENT

Corn oil

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histopathologically verified adenocarcinoma of the colon or rectum and planned standard adjuvant treatment with capecitabine in combination with oxaliplatin. * ECOG performance status 0-2 (measurement of a patient's function in terms of self-care, daily activity and physical ability. * Written and orally informed informed consent Exclusion Criteria: * Inability to speak, read, and understand Danish. * Previous treatment with neurotoxic chemotherapy. * Neurological (including neuropathy) or psychiatric disorders, diabetes or other significant medical conditions. * Alcohol or drug abuse. * Sensory disturbances in the feet * Spinal stenosis. * Vascular disease (Fontaine grade II or more). * Known allergy to fish, fish oil or corn oil * Fertile patients not willing to use effective methods of contraception during treatment or abstinence. * Daily intake of oil supplements and not willing to stop during the trial period. * Lack of consent to skin biopsy

Locations (1)

Deparment of Oncology, Vejle Hospital

Vejle, Denmark

RECRUITING

Outcomes

Primary Outcomes

Incidence of chemotherapy induced peripheral neuropathy (CIPN) 8 months after start of adjuvant chemotherapy

Number of patients who meet the criteria for CIPN: relevant symptoms evaluated by a medical doctor, incl one of the following: abnormal vibration test or, abnormal nerve conduction test by DPN check device or, abnormal pinprick test or, abnormal skin biopsy.

Time frame: 8 months after start of adjuvant chemotherapy

Secondary Outcomes

Intensity of CIPN-related neuropathic pain 8 months after adjuvant chemotherapy according to the Numeric Rating Scale (NRS)

Average over the past 24 hours measured by NRS (scale from 0-10 with 0=no pain and 10=worst pain imaginable)

Time frame: 8 months after start of adjuvant chemotherapy

Change in severity of CIPN from baseline to 8 months after start of adjuvant chemotherapy according to the EORCT QLQ-CIPN 20 questionnaire

EORCT QLQ-CIPN 20 = the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy Induced Peripheral Neuropathy

Time frame: 8 months after start of adjuvant chemotherapy

Central Contacts

Nina Lykkegaard Gehr, MD.

CONTACT

+45 26618559 ninalykgehr@clin.au.dk

Karin Larsen

CONTACT

+ 45 Karin.Larsen1@rsyd.dk

Data from ClinicalTrials.gov

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