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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Peripheral Neuropathy
• Intervention / Treatment: Dietary supplement: Fish oil; Dietary supplement: Corn oil

Detailed Description

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
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karin Larsen; Phone Number: + 45; Email: Karin.Larsen1@rsyd.dk
• Study Contact Backup: Name: Malene Nielsen, MD.; Phone Number: +45 26823726; Email: Malene.Nielsen6@rsyd.dk

Study Locations

• Denmark
  • Aalborg, Denmark
    • Recruiting
    • Department of Oncology, AAUH
    • Contact: Laurids Østergaard Poulsen
  • Aarhus, Denmark
    • Recruiting
    • Department of Oncology, AUH
    • Contact: Christian Hviid
  • Sønderborg, Denmark
    • Recruiting
    • Department of Oncology
    • Contact: Stinne Husum
  • Vejle, Denmark
    • Recruiting
    • Department of Oncology, Vejle Hospital
    • Contact: Malene Nielsen, MD; Phone Number: +4526823726; Email: Malene.Nielsen6@rsyd.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fish oil; 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; Fish oil containing poly unsaturated fatty acids.
Placebo Comparator: Corn oil; 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; Corn oil

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Vejle Hospital
• Investigators: Study Director: Lise Ventzel, MD PHD, medical doctor at Vejle Hospital, University Hospital of southern Denmark

Publications and helpful links

General Publications

• Gehr NL, Karlsson P, Timm S, Christensen S, Hvid CA, Peric J, Hansen TF, Lauritzen L, Finnerup NB, Ventzel L. Study protocol: fish oil supplement in prevention of oxaliplatin-induced peripheral neuropathy in adjuvant colorectal cancer patients - a randomized controlled trial. (OxaNeuro). BMC Cancer. 2024 Feb 3;24(1):168. doi: 10.1186/s12885-024-11856-z.

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: May 30, 2022
• First Submitted That Met QC Criteria: May 30, 2022
• First Posted (Actual): June 3, 2022

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Site; Neoplasms; Neuromuscular Diseases; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms; Peripheral Nervous System Diseases; Lipids; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Plant Preparations; Biological Products; Complex Mixtures; Plant Oils; Oils; Dietary Fats; Fats; Dietary Fats, Unsaturated; Fats, Unsaturated; Fish Oils; Corn Oil
• Other Study ID Numbers: OxaNeuro

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Due to restrictions related to Danish law protecting patient privacy, the data used in this study can be made available if it complies with GDPR and through an application to the Region of Southern Denmark
• IPD Sharing Time Frame: Due to restrictions related to Danish law protecting patient privacy, the data used in this study can be made available if it complies with GDPR and through an application to the Region of Southern Denmark
• IPD Sharing Access Criteria: Due to restrictions related to Danish law protecting patient privacy, the data used in this study can be made available if it complies with GDPR and through an application to the Region of Southern Denmark
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No