Prevention of Oxaliplatin-induced Nerve Damage in the Body's Extremities
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVejle Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Fish oil
Dietary supplementFish oil containing poly unsaturated fatty acids.
Corn oil
Dietary supplementCorn oil
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Fish oilActive comparator 1 intervention
Group B: Corn oilPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
8 months after start of adjuvant chemotherapySecondary outcomes
1
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)
Time frame
8 months after start of adjuvant chemotherapy2
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
Time frame
8 months after start of adjuvant chemotherapySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov