RecruitingNot ApplicableNCT05404230
Prevention of Oxaliplatin-induced Nerve Damage in the Body's Extremities
Prevention of Oxaliplatin-induced Peripheral Neuropathy - a Randomized Controlled Trial
Sponsor
Vejle Hospital
Enrollment
120 participants
Start Date
Jul 15, 2022
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria3
- 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 Criteria11
- 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
Interventions
DIETARY_SUPPLEMENTFish oil
Fish oil containing poly unsaturated fatty acids.
DIETARY_SUPPLEMENTCorn oil
Corn oil
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05404230