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

Launched by VEJLE HOSPITAL · May 30, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how a type of supplement called polyunsaturated fatty acids might help prevent nerve damage in the hands and feet of patients receiving oxaliplatin-based chemotherapy after surgery for colorectal cancer. Nerve damage, known as peripheral neuropathy, can cause pain, tingling, or numbness in these areas, affecting daily life. The researchers want to see if adding these fatty acids to treatment can reduce these side effects.

To be part of this study, participants need to be adults aged 65 to 74 who have been diagnosed with colon or rectal cancer and are about to start a specific chemotherapy treatment. They should be able to take care of themselves and understand the study's information. However, individuals with a history of certain neurological issues, previous neurotoxic chemotherapy, or those who cannot communicate in Danish will not be eligible. Participants will need to agree to some procedures, like a skin biopsy, and will be asked to stop taking other oil supplements during the trial. If you join, you’ll be helping researchers understand how to better manage side effects from cancer treatment.

Gender

ALL

Eligibility criteria

• 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