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

Colorectal Cancer Clinical Trial

— OxaNeuro  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05404230
• Other study ID #: OxaNeuro
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2022
• Est. completion date: December 2026

Study information

• Verified date: September 2023
• Source: Vejle Hospital
• Contact: Nina Lykkegaard Gehr, MD.
• Phone: +45 26618559
• Email: ninalykgehr[@]clin.au.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2026
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Peripheral Nervous System Diseases
• Peripheral Neuropathy

Intervention

Dietary Supplement:
• Fish oil
Fish oil containing poly unsaturated fatty acids.
• Corn oil
Corn oil

Locations

Country	Name	City	State
Denmark	Deparment of Oncology, Vejle Hospital	Vejle

Sponsors (1)

Lead Sponsor	Collaborator
Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of chemotherapy induced peripheral neuropathy (CIPN) 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.	8 months after start of adjuvant chemotherapy
Secondary	Intensity of CIPN-related neuropathic pain 8 months after adjuvant chemotherapy according to the Numeric Rating Scale (NRS)	Average over the past 24 hours measured by NRS (scale from 0-10 with 0=no pain and 10=worst pain imaginable)	8 months after start of adjuvant chemotherapy
Secondary	Change in severity of CIPN from baseline to 8 months after start of adjuvant chemotherapy according to the EORCT QLQ-CIPN 20 questionnaire	EORCT QLQ-CIPN 20 = the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy Induced Peripheral Neuropathy	8 months after start of adjuvant chemotherapy