Study protocol: fish oil supplement in prevention of oxaliplatin-induced peripheral neuropathy in adjuvant colorectal cancer patients - a randomized controlled trial. (OxaNeuro)

Nina Lykkegaard Gehr, Páll Karlsson, Signe Timm, Signe Christensen, Christian Andreas Hvid, Jana Peric, Torben Frøstrup Hansen, Lotte Lauritzen, Nanna Brix Finnerup, Lise Ventzel

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Abstract

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.

Original languageEnglish
JournalBMC Cancer
Volume24
Pages (from-to)168
ISSN1471-2407
DOIs
Publication statusPublished - 3 Feb 2024

Keywords

  • Humans
  • Oxaliplatin/adverse effects
  • Fish Oils/therapeutic use
  • Quality of Life
  • Peripheral Nervous System Diseases/chemically induced
  • Dietary Supplements
  • Adjuvants, Immunologic/therapeutic use
  • Colorectal Neoplasms/drug therapy
  • Randomized Controlled Trials as Topic
  • Multicenter Studies as Topic
  • Colorectal cancer
  • Inflammation
  • Fish oil
  • Randomized controlled trial
  • Quality of life
  • Oxaliplatin
  • Neurofilament light
  • Chemotherapy-induced peripheral neuropathy
  • Omega-3 fatty acids
  • Specialized proresolving mediators

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