Peripheral Neuropathy, Colorectal Cancer
Conditions
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.
Interventions
DIETARY_SUPPLEMENTFish oil
Fish oil containing poly unsaturated fatty acids.
DIETARY_SUPPLEMENTCorn oil
Corn oil
Sponsors
Vejle Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 |
Countries
Denmark
Contacts
CONTACTNina Lykkegaard Gehr, MD.
CONTACTKarin Larsen
STUDY_DIRECTORLise Ventzel, MD PHD
medical doctor at Vejle Hospital, University Hospital of southern Denmark
Outcome results
None listed