TY - JOUR
T1 - Study protocol
T2 - fish oil supplement in prevention of oxaliplatin-induced peripheral neuropathy in adjuvant colorectal cancer patients - a randomized controlled trial. (OxaNeuro)
AU - Gehr, Nina Lykkegaard
AU - Karlsson, Páll
AU - Timm, Signe
AU - Christensen, Signe
AU - Hvid, Christian Andreas
AU - Peric, Jana
AU - Hansen, Torben Frøstrup
AU - Lauritzen, Lotte
AU - Finnerup, Nanna Brix
AU - Ventzel, Lise
N1 - © 2024. The Author(s).
PY - 2024/2/3
Y1 - 2024/2/3
N2 - Background: Oxaliplatin-induced peripheral neuropathy (OIPN) in general and painful OIPN in particular is a debilitating late effect that severely affects cancer survivors’ quality of life and causes premature cessation of potentially lifesaving treatment. No preventive treatments and no effective treatment for chronic OIPN exist despite many attempts. One of several suggested mechanisms includes neuroinflammation as a contributing factor to OIPN. Fish oil containing long-chain n-3 polyunsaturated fatty acids (n-3 LCPUFAs) are precursors to specialized proresolving mediators that mediate the resolution of inflammation. Our primary hypothesis is that a high supplementation of n-3 LCPUFAs will lower the prevalence and severity of OIPN. Methods: The OxaNeuro project is an investigator-initiated, multicenter, double-blinded, randomized, placebo-controlled clinical study. We will include 120 patients eligible to receive adjuvant oxaliplatin after colorectal cancer surgery. Patients will receive fish oil capsules containing n-3 LCPUFAs or corn oil daily for 8 months. The primary endpoint is the prevalence of OIPN at 8 months defined as relevant symptoms, including one of the following: abnormal nerve conduction screening, abnormal vibration threshold test, abnormal skin biopsy, or abnormal pinprick test. Additional endpoints include the intensity and severity of OIPN-related neuropathic pain, patient-reported OIPN symptoms, quality of life, mental health symptoms, body composition, and cognitive evaluation. Furthermore, we will evaluate inflammatory biomarkers in blood samples and skin biopsies, including the potential OIPN biomarker neurofilament light protein (NfL) which will be measured before each cycle of chemotherapy. Discussion: If readily available fish oil supplementation alleviates OIPN prevalence and severity, it will significantly improve the lives of both cancer survivors and palliative cancer patients receiving oxaliplatin; it will improve their quality of life, optimize chemotherapeutic treatment plans by lowering the need for dose reduction or premature cessation, and potentially increase survival. Trial registration: ClinicalTrial.gov identifier: NCT05404230 Protocol version: 1.2, April 25
th.
AB - Background: Oxaliplatin-induced peripheral neuropathy (OIPN) in general and painful OIPN in particular is a debilitating late effect that severely affects cancer survivors’ quality of life and causes premature cessation of potentially lifesaving treatment. No preventive treatments and no effective treatment for chronic OIPN exist despite many attempts. One of several suggested mechanisms includes neuroinflammation as a contributing factor to OIPN. Fish oil containing long-chain n-3 polyunsaturated fatty acids (n-3 LCPUFAs) are precursors to specialized proresolving mediators that mediate the resolution of inflammation. Our primary hypothesis is that a high supplementation of n-3 LCPUFAs will lower the prevalence and severity of OIPN. Methods: The OxaNeuro project is an investigator-initiated, multicenter, double-blinded, randomized, placebo-controlled clinical study. We will include 120 patients eligible to receive adjuvant oxaliplatin after colorectal cancer surgery. Patients will receive fish oil capsules containing n-3 LCPUFAs or corn oil daily for 8 months. The primary endpoint is the prevalence of OIPN at 8 months defined as relevant symptoms, including one of the following: abnormal nerve conduction screening, abnormal vibration threshold test, abnormal skin biopsy, or abnormal pinprick test. Additional endpoints include the intensity and severity of OIPN-related neuropathic pain, patient-reported OIPN symptoms, quality of life, mental health symptoms, body composition, and cognitive evaluation. Furthermore, we will evaluate inflammatory biomarkers in blood samples and skin biopsies, including the potential OIPN biomarker neurofilament light protein (NfL) which will be measured before each cycle of chemotherapy. Discussion: If readily available fish oil supplementation alleviates OIPN prevalence and severity, it will significantly improve the lives of both cancer survivors and palliative cancer patients receiving oxaliplatin; it will improve their quality of life, optimize chemotherapeutic treatment plans by lowering the need for dose reduction or premature cessation, and potentially increase survival. Trial registration: ClinicalTrial.gov identifier: NCT05404230 Protocol version: 1.2, April 25
th.
KW - Humans
KW - Oxaliplatin/adverse effects
KW - Fish Oils/therapeutic use
KW - Quality of Life
KW - Peripheral Nervous System Diseases/chemically induced
KW - Dietary Supplements
KW - Adjuvants, Immunologic/therapeutic use
KW - Colorectal Neoplasms/drug therapy
KW - Randomized Controlled Trials as Topic
KW - Multicenter Studies as Topic
KW - Colorectal cancer
KW - Inflammation
KW - Fish oil
KW - Randomized controlled trial
KW - Quality of life
KW - Oxaliplatin
KW - Neurofilament light
KW - Chemotherapy-induced peripheral neuropathy
KW - Omega-3 fatty acids
KW - Specialized proresolving mediators
UR - http://www.scopus.com/inward/record.url?scp=85183807222&partnerID=8YFLogxK
U2 - 10.1186/s12885-024-11856-z
DO - 10.1186/s12885-024-11856-z
M3 - Journal article
C2 - 38308227
SN - 1471-2407
VL - 24
SP - 168
JO - BMC Cancer
JF - BMC Cancer
ER -