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

Not Applicable

Recruiting

• Conditions: Peripheral Neuropathy; Colorectal Cancer

• Registration Number: NCT05404230
• Lead Sponsor: Vejle Hospital

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.

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.

Study Timeline

• Study First Submitted: 2022-05-30
• Study First Submitted QC: 2022-05-30
• Study First Posted: 2022-06-03
• Study Start: 2022-07-15
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-28
• Primary Completion: 2026-03
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of chemotherapy induced peripheral neuropathy (CIPN) 8 months after start of adjuvant chemotherapy	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 Outcome Measures

Name	Time	Method
Change in severity of CIPN from baseline to 8 months after start of adjuvant chemotherapy according to the EORCT QLQ-CIPN 20 questionnaire	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
Intensity of CIPN-related neuropathic pain 8 months after adjuvant chemotherapy according to the Numeric Rating Scale (NRS)	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)

Trial Locations

Locations (1)

Deparment of Oncology, Vejle Hospital; 🇩🇰 Vejle, Denmark