Status:
RECRUITING
Prevention of Oxaliplatin-induced Nerve Damage in the Body's Extremities
Lead Sponsor:
Vejle Hospital
Conditions:
Peripheral Neuropathy
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
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 ox...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05404230
Start Date
July 15 2022
End Date
December 1 2026
Last Update
March 28 2025
Active Locations (1)
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1
Deparment of Oncology, Vejle Hospital
Vejle, Denmark