Back to resultsPrevention of Oxaliplatin-induced Nerve Damage in the Body's Extremities (OxaNeuro)
Primary Purpose
Peripheral Neuropathy, Colorectal Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Fish oil
Corn oil
Sponsored by
About this trial
This is an interventional prevention trial for Peripheral Neuropathy
Eligibility Criteria
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
Sites / Locations
- Deparment of Oncology, Vejle HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Fish oil
Corn oil
Arm Description
4 capsules containing n-3 poly unsaturated fatty acids (EPA and DHA) with a total concentration of 3 g per day. 4 capsules per day for 8 months
4 capsules containing n-6 poly unsaturated fatty acids in a total concentration of 2 g per day. 4 capsules per day for 8 months. Corn oil is regularly used in the kitchen and the daily dose in the study is the equivalent of adding an extra spoon of food oil when cooking. It has no known effect on the parameters we want to examine.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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)
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05404230
Brief Title
Prevention of Oxaliplatin-induced Nerve Damage in the Body's Extremities
Acronym
OxaNeuro
Official Title
Prevention of Oxaliplatin-induced Peripheral Neuropathy - a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vejle Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Neuropathy, Colorectal Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fish oil
Arm Type
Active Comparator
Arm Description
4 capsules containing n-3 poly unsaturated fatty acids (EPA and DHA) with a total concentration of 3 g per day.
4 capsules per day for 8 months
Arm Title
Corn oil
Arm Type
Placebo Comparator
Arm Description
4 capsules containing n-6 poly unsaturated fatty acids in a total concentration of 2 g per day.
4 capsules per day for 8 months.
Corn oil is regularly used in the kitchen and the daily dose in the study is the equivalent of adding an extra spoon of food oil when cooking. It has no known effect on the parameters we want to examine.
Intervention Type
Dietary Supplement
Intervention Name(s)
Fish oil
Intervention Description
Fish oil containing poly unsaturated fatty acids.
Intervention Type
Dietary Supplement
Intervention Name(s)
Corn oil
Intervention Description
Corn oil
Primary Outcome Measure Information:
Title
Incidence of chemotherapy induced peripheral neuropathy (CIPN) 8 months after start of adjuvant chemotherapy
Description
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
Secondary Outcome Measure Information:
Title
Intensity of CIPN-related neuropathic pain 8 months after adjuvant chemotherapy according to the Numeric Rating Scale (NRS)
Description
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
Title
Change in severity of CIPN from baseline to 8 months after start of adjuvant chemotherapy according to the EORCT QLQ-CIPN 20 questionnaire
Description
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 chemotherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nina Lykkegaard Gehr, MD.
Phone
+45 26618559
Email
ninalykgehr@clin.au.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Karin Larsen
Phone
+ 45
Email
Karin.Larsen1@rsyd.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lise Ventzel, MD PHD
Organizational Affiliation
medical doctor at Vejle Hospital, University Hospital of southern Denmark
Official's Role
Study Director
Facility Information:
Facility Name
Deparment of Oncology, Vejle Hospital
City
Vejle
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nina L Gehr, MD
Phone
+4526618559
Email
ninalykgehr@clin.au.dk
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Due to restrictions related to Danish law protecting patient privacy, the data used in this study can be made available if it complies with GDPR and through an application to the Region of Southern Denmark
IPD Sharing Time Frame
Due to restrictions related to Danish law protecting patient privacy, the data used in this study can be made available if it complies with GDPR and through an application to the Region of Southern Denmark
IPD Sharing Access Criteria
Due to restrictions related to Danish law protecting patient privacy, the data used in this study can be made available if it complies with GDPR and through an application to the Region of Southern Denmark
Learn more about this trial
Prevention of Oxaliplatin-induced Nerve Damage in the Body's Extremities
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