NCT05404230 Prevention of Oxaliplatin-induced Nerve Damage in the Body's Extremities
| NCT ID | NCT05404230 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vejle Hospital |
| Condition | Peripheral Neuropathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2022-07-15 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2022-07-15 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 after surgery for colorectal cancer.
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
Contact & Investigator
Lise Ventzel, MD PHD
STUDY DIRECTOR
medical doctor at Vejle Hospital, University Hospital of southern Denmark
Frequently Asked Questions
Who can join the NCT05404230 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Peripheral Neuropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05404230 currently recruiting?
Yes, NCT05404230 is actively recruiting participants. Contact the research team at Malene.Nielsen6@rsyd.dk for enrollment information.
Where is the NCT05404230 trial being conducted?
This trial is being conducted at Aalborg, Denmark, Aarhus, Denmark, Sønderborg, Denmark, Vejle, Denmark.
Who is sponsoring the NCT05404230 clinical trial?
NCT05404230 is sponsored by Vejle Hospital. The principal investigator is Lise Ventzel, MD PHD at medical doctor at Vejle Hospital, University Hospital of southern Denmark. The trial plans to enroll 120 participants.