Prevention of Oxaliplatin-induced Nerve Damage in the Body's Extremities
Recruiting · NCT05404230 · Interventional (participants receive a specific treatment) · Lead sponsor: Vejle Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Corn oilFish oil
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
4 locations listed.
- Department of Oncology, AAUH - Aalborg, Denmark
- Department of Oncology, AUH - Aarhus, Denmark
- Department of Oncology - Sønderborg, Denmark
- Department of Oncology, Vejle Hospital - Vejle, Denmark