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Recruiting NCT05404230

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

No phase Interventional Peripheral Neuropathy Colorectal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fish oil, Corn oil.
Who it may be relevant to
Registry conditions: Peripheral Neuropathy, Colorectal Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed 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.

Interventions

  • Dietary supplement Fish oil
    Fish oil containing poly unsaturated fatty acids.
  • Dietary supplement Corn oil
    Corn oil

Primary outcome measures

  • Incidence of chemotherapy induced peripheral neuropathy (CIPN) 8 months after start of adjuvant chemotherapy [Time frame: 8 months after start of adjuvant chemotherapy]
Secondary outcome measures (2)
  • 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]
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

Denmark · 4 centers
  • Department of Oncology, AAUH — Aalborg
  • Department of Oncology, AUH — Aarhus
  • Department of Oncology — Sønderborg
  • Department of Oncology, Vejle Hospital — Vejle

Publications

  • Gehr NL, Karlsson P, Timm S, Christensen S, Hvid CA, Peric J, Hansen TF, Lauritzen L, Finnerup NB, Ventzel L. Study protocol: fish oil supplement in prevention of oxaliplatin-induced peripheral neuropathy in adjuvant colorectal cancer patients - a randomized controlled trial. (OxaNeuro). BMC Cancer. 2024 Feb 3;24(1):168. doi: 10.1186/s12885-024-11856-z. PMID 38308227

Identifiers

NCT: NCT05404230 · OxaNeuro

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗