Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05404230

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

Led by Vejle Hospital · Updated on 2026-04-03

120

Participants Needed

1

Research Sites

228 weeks

Total Duration

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AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histopathologically verified adenocarcinoma of the colon or rectum and planned standard adjuvant treatment with capecitabine in combination with oxaliplatin.
  • ECOG performance status 0-2.
  • Written and orally informed informed consent.
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Deparment of Oncology, Vejle Hospital

Vejle, Denmark

Actively Recruiting

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Research Team

N

Nina Lykkegaard Gehr, MD.

CONTACT

K

Karin Larsen

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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