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

Vejle Hospital

Status: Enrolling

Conditions: Peripheral Neuropathy; Colorectal Cancer

Treatments: Dietary Supplement: Corn oil; Dietary Supplement: Fish oil

Study type: Interventional

Funder types: Other

Identifiers

NCT05404230

OxaNeuro

Details and patient eligibility

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.

Full description

The primary objective of the present study is to examine if a high dosage of n-3 PUFA reduces the incidence and severity of chemotherapy-induced peripheral neuropathy (CIPN) 8 months after adjuvant oxaliplatin following surgery for high-risk colorectal cancer.

An additional aim is to investigate whether n-3 PUFAs have an effect on nutritional status, cognition and mental status. Inflammatory mechanisms and biomarkers of CIPN in skin biopsies and in blood will be explored.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups, including a placebo group

Fish oil

Active Comparator group

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

Treatment:

Dietary Supplement: Fish oil

Corn oil

Placebo Comparator group

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.

Treatment:

Dietary Supplement: Corn oil