Preventing nerve damage from chemotherapy in colorectal cancer patients
Prevention of Oxaliplatin-induced Peripheral Neuropathy - a Randomized Controlled Trial
This study is testing if high doses of omega-3 fatty acids can help prevent nerve damage in colorectal cancer patients who are getting chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vejle Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Vejle) |
| Trial ID | NCT05404230 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of high doses of polyunsaturated fatty acids (PUFAs) on nerve damage in patients receiving oxaliplatin-based chemotherapy after surgery for colorectal cancer. The primary goal is to determine if n-3 PUFAs can reduce the incidence and severity of chemotherapy-induced peripheral neuropathy (CIPN) eight months post-treatment. Additionally, the study will assess the impact of n-3 PUFAs on nutritional status, cognition, and mental health, while exploring inflammatory mechanisms and biomarkers related to CIPN through skin biopsies and blood samples.
Who should consider this trial
Good fit: Ideal candidates are patients with histologically confirmed colorectal cancer who are scheduled to receive oxaliplatin-based chemotherapy.
Not a fit: Patients with pre-existing neurological disorders or those who have previously received neurotoxic chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce nerve damage and improve the quality of life for patients undergoing chemotherapy for colorectal cancer.
How similar studies have performed: While the use of PUFAs in this context is relatively novel, previous studies have shown potential benefits of fatty acids in managing neuropathy, suggesting a promising avenue for further exploration.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Vejle
- Deparment of Oncology, Vejle Hospital — Vejle, Denmark (Recruiting)
Study contacts
- Study coordinator: Nina Lykkegaard Gehr, MD.
- Email: ninalykgehr@clin.au.dk
- Phone: +45 26618559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.