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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-15

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Peripheral Neuropathy Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Fish oil

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

Group Type ACTIVE_COMPARATOR

Fish oil

Intervention Type DIETARY_SUPPLEMENT

Fish oil containing poly unsaturated fatty acids.

Corn oil

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.

Group Type PLACEBO_COMPARATOR

Corn oil

Intervention Type DIETARY_SUPPLEMENT

Corn oil

Interventions

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Fish oil

Fish oil containing poly unsaturated fatty acids.

Intervention Type DIETARY_SUPPLEMENT

Corn oil

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No