Fish Oil
Dietary SupplementFish oil containing poly unsaturated fatty acids.
NCT Number: NCT05404230
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Department of Oncology, AAUH, Aalborg, Denmark
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Fish oil containing poly unsaturated fatty acids.
Corn oil
Time frame: 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 chemotherapy
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 chemotherapy
EORCT QLQ-CIPN 20 = the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy Induced Peripheral Neuropathy
Contact information is provided by the study sponsor or research team.
Karin Larsen
CONTACT
+ 45
Malene Nielsen, MD.
CONTACT
Vejle Hospital
Other
Prevention of Oxaliplatin-induced Peripheral Neuropathy - a Randomized Controlled Trial
Acronym: OxaNeuro
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06499129
Anxiety, Anxiety Disorders
Konya, Meram, Turkey (Türkiye)
View Trial DetailsNCT07236515
Nervous System Diseases, Neuromuscular Diseases
Meyrin, Switzerland
View Trial DetailsNCT05950659
Cardiovascular Diseases, Diabetes
Baltimore, Maryland, United States
View Trial DetailsNCT07109817
Breast Cancer, Breast Diseases
The Bronx, New York, United States
View Trial Details