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NCT Number: NCT05404230

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Oncology, AAUH, Aalborg, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fish Oil

Dietary Supplement

Fish oil containing poly unsaturated fatty acids.

corn oil

Dietary Supplement

Corn oil

Primary outcomes

  1. Incidence of chemotherapy induced peripheral neuropathy (CIPN) 8 months after start of adjuvant chemotherapy

    Time frame: 8 months after start of adjuvant chemotherapy

    Number of patients who meet the criteria for CIPN: relevant symptoms evaluated by a medical doctor, incl one of the following: abnormal vibration test or, abnormal nerve conduction test by DPN check device or, abnormal pinprick test or, abnormal skin biopsy.

Secondary outcomes

  1. Intensity of CIPN-related neuropathic pain 8 months after adjuvant chemotherapy according to the Numeric Rating Scale (NRS)

    Time frame: 8 months after start of adjuvant chemotherapy

    Average over the past 24 hours measured by NRS (scale from 0-10 with 0=no pain and 10=worst pain imaginable)

  2. Change in severity of CIPN from baseline to 8 months after start of adjuvant chemotherapy according to the EORCT QLQ-CIPN 20 questionnaire

    Time frame: 8 months after start of adjuvant chemotherapy

    EORCT QLQ-CIPN 20 = the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy Induced Peripheral Neuropathy

Study contacts

Contact information is provided by the study sponsor or research team.

Karin Larsen

CONTACT

[email protected]

+ 45

Malene Nielsen, MD.

CONTACT

[email protected]

+45 26823726

Sponsors and collaborators

Lead sponsor

Vejle Hospital

Other

Registry information

Official study title

Prevention of Oxaliplatin-induced Peripheral Neuropathy - a Randomized Controlled Trial

Acronym: OxaNeuro

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Jun 3, 2022
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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