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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prevention of Oxaliplatin-induced Peripheral Neuropathy - a Randomized Controlled Trial

Conditions
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Peripheral Neuropathy, Colorectal Cancer

Intervention / Treatment
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* Dietary Supplement: Fish oil
* Dietary Supplement: Corn oil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fish oil<br>4 capsules containing n-3 poly unsaturated fatty acids (EPA and DHA) with a total concentration of 3 g per day. 4 capsules per day for 8 months | Dietary Supplement: Fish oil<br>* Fish oil containing poly unsaturated fatty acids.<br>|
| Placebo Comparator: Corn oil<br>4 capsules containing n-6 poly unsaturated fatty acids in a total concentration of 2 g per day. 4 capsules per day for 8 months. Corn oil is regularly used in the kitchen and the daily dose in the study is the equivalent of adding an extra spoon of food oil when cooking. It has no known effect on the parameters we want to examine. | Dietary Supplement: Corn oil<br>* Corn oil<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 8 months after start of adjuvant chemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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 | 8 months after start of adjuvant chemotherapy |