Clinical trial · Interventional
Prevention of Oxaliplatin-induced Nerve Damage in the Body's Extremities
Prevention of Oxaliplatin-induced Peripheral Neuropathy - a Randomized Controlled Trial
NCT05404230CI-TRIAL-00111970OxaNeurorecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Peripheral Neuropathy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Corn oil | Dietary Supplement | — | UNRESOLVED |
| Fish oil | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Fish oil
- description
- 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
- interventionNames
- Dietary Supplement: Fish oil
- type
- PLACEBO_COMPARATOR
- label
- Corn oil
- description
- 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.
- interventionNames
- Dietary Supplement: Corn oil
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDGehr 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