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

NCT05404230 | Recruiting

• 1 other identifier: OxaNeuro
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peripheral Neuropathy; Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  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

  8 months after start of adjuvant chemotherapy

Study Arms (2)

Fish oil

ACTIVE COMPARATOR

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

Corn oil

PLACEBO COMPARATOR

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

Interventions

Fish oil DIETARY_SUPPLEMENT

Fish oil containing poly unsaturated fatty acids.

Fish oil

Corn oil DIETARY_SUPPLEMENT

Corn oil

Corn oil

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vejle Hospital: lead

Study Sites (1)

Deparment of Oncology, Vejle Hospital

Vejle, Denmark

RECRUITING

Related Publications (1)

• 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.

  PMID: 38308227 DERIVED

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Colorectal Neoplasms

Interventions

Fish Oils; Corn Oil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Oils; Lipids; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fats, Unsaturated; Plant Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Lise Ventzel, MD PHD

  medical doctor at Vejle Hospital, University Hospital of southern Denmark

  STUDY DIRECTOR

Central Study Contacts

Nina Lykkegaard Gehr, MD.

CONTACT

+45 26618559; ninalykgehr@clin.au.dk

Karin Larsen

CONTACT

+ 45; Karin.Larsen1@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2022
• First Posted: June 3, 2022
• Study Start: July 15, 2022
• Primary Completion: March 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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
• 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

Locations

DK (1)