Preventing nerve damage from chemotherapy in colorectal cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of high doses of polyunsaturated fatty acids (PUFAs) on nerve damage in patients receiving oxaliplatin-based chemotherapy after surgery for colorectal cancer. The primary goal is to determine if n-3 PUFAs can reduce the incidence and severity of chemotherapy-induced peripheral neuropathy (CIPN) eight months post-treatment. Additionally, the study will assess the impact of n-3 PUFAs on nutritional status, cognition, and mental health, while exploring inflammatory mechanisms and biomarkers related to CIPN through skin biopsies and blood samples.

Why it matters

Who can join: the full rules

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's running

• Department of Oncology, AAUH
  Aalborg, Denmark Recruiting
• Department of Oncology, AUH
  Aarhus, Denmark Recruiting
• Department of Oncology
  Sønderborg, Denmark Recruiting
• Department of Oncology, Vejle Hospital
  Vejle, Denmark Recruiting

Study contacts

• Study coordinator: Malene Nielsen, MD.
• Email: Malene.Nielsen6@rsyd.dk
• Phone: +45 26823726

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.