Peripheral NeuropathyOxaNeuroNCT05404230
Prevention of Oxaliplatin-induced Nerve Damage in the Body's Extremities
A study testing Fish oil and Corn oil in people with Peripheral Neuropathy and Colorectal Cancer, run by Vejle Hospital at 4 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Neuropathy, Colorectal Cancer
- What is being tested?
- Fish oil and Corn oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 4 sitesDenmark
- Study dates
- 15 Jul 2022to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark4 sites, 4 recruiting
- Recruiting
Department of Oncology, AAUH
Aalborg
Laurids Østergaard Poulsen
- Recruiting
Department of Oncology, AUH
Aarhus
Christian Hviid
- Recruiting
Department of Oncology
Sønderborg
Stinne Husum
- Recruiting
Department of Oncology, Vejle Hospital
Vejle
Malene Nielsen, MD, +4526823726, Malene.Nielsen6@rsyd.dk
About this study
Official title: Prevention of Oxaliplatin-induced Peripheral Neuropathy - a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Peripheral Neuropathy, Colorectal Cancer
- Being tested
- Fish oil, Corn oil
- Medical subject headings
- Peripheral Nervous System Diseases, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish oilDietary supplement
Fish oil containing poly unsaturated fatty acids.
Corn oilDietary supplement
Corn oil
| Study group | Role | What they receive |
|---|---|---|
| Fish oil | Active comparator | 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 Receives: Dietary Supplement: Fish oil |
| Corn oil | Placebo comparator | 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. Receives: Dietary Supplement: Corn oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 months after start of adjuvant chemotherapy
Secondary outcomes (2)
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)
Measured: 8 months after start of adjuvant chemotherapy
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
Measured: 8 months after start of adjuvant chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start15 Jul 2022
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lise Ventzel, MD PHD, Study director, medical doctor at Vejle Hospital, University Hospital of southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05404230
- Sponsor's protocol ID
- OxaNeuro
- Acronym
- OxaNeuro
- Status last verified
- May 2026
- First submitted
- 30 May 2022
- Last updated
- 19 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
Gehr NL, Karlsson P, Timm S, Christensen S, Hvid CA, Peric J, Hansen TF, Lauritzen L, Finnerup NB, Ventzel L. Study protocol: fish oil supplement in prevention of oxaliplatin-induced peripheral neuropathy in adjuvant colorectal cancer patients - a randomized controlled trial. (OxaNeuro). BMC Cancer. 2024 Feb 3;24(1):168. doi: 10.1186/s12885-024-11856-z.
PubMed 38308227
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Oxaliplatin-induced Peripheral Neuropathy - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05404230
- Acronym / sponsor ID
- OxaNeuro / OxaNeuro
- Conditions
- Peripheral Neuropathy, Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 3 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fish oil | Active comparator | Dietary Supplement: Fish oil4 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 |
| Corn oil | Placebo comparator | Dietary Supplement: Corn oil4 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fish oilFish oil containing poly unsaturated fatty acids. | Dietary supplement | Fish oil |
| Corn oilCorn oil | Dietary supplement | Corn oil |
Primary outcome
Incidence of chemotherapy induced peripheral neuropathy (CIPN) 8 months after start of adjuvant chemotherapy
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.
2 secondary outcomes
Intensity of CIPN-related neuropathic pain 8 months after adjuvant chemotherapy according to the Numeric Rating Scale (NRS)
Time frame: 8 months after start of adjuvant chemotherapy
Change in severity of CIPN from baseline to 8 months after start of adjuvant chemotherapy according to the EORCT QLQ-CIPN 20 questionnaire
Time frame: 8 months after start of adjuvant chemotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Derived from this study: PubMed 38308227Gehr NL, Karlsson P, Timm S, Christensen S, Hvid CA, Peric J, Hansen TF, Lauritzen L, Finnerup NB, Ventzel L. Study protocol: fish oil supplement in prevention of oxaliplatin-induced peripheral neuropathy in adjuvant colorectal cancer patients - a randomized controlled trial. (OxaNeuro). BMC Cancer. 2024 Feb 3;24(1):168. doi: 10.1186/s12885-024-11856-z.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lise Ventzel, MD PHD study director
medical doctor at Vejle Hospital, University Hospital of southern Denmark
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fish oil and Corn oil in people with Peripheral Neuropathy and Colorectal Cancer, run by Vejle Hospital at 4 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Malene Nielsen, MD. (+45 26823726, Malene.Nielsen6@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of chemotherapy induced peripheral neuropathy (CIPN) 8 months after start of adjuvant chemotherapy (time frame: 8 months after start of adjuvant chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05404230, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.