OxaNeuro: Prevention of Oxaliplatin-induced Nerve Damage in the Body's Extremities

Sponsor

Vejle Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05404230

Collaborator

(none)

120

Enrollment

Location

Arms

52.6

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Neuropathy Colorectal Cancer	Dietary Supplement: Fish oil Dietary Supplement: Corn oil	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

Official Title:

Prevention of Oxaliplatin-induced Peripheral Neuropathy - a Randomized Controlled Trial

Actual Study Start Date :

Jul 15, 2022

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Dec 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Fish oil 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	Dietary Supplement: Fish oil Fish oil containing poly unsaturated fatty acids.
Placebo Comparator: Corn oil 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.	Dietary Supplement: Corn oil Corn oil

Arm

Intervention/Treatment

Active Comparator: Fish oil

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

Dietary Supplement: Fish oil

Fish oil containing poly unsaturated fatty acids.

Placebo Comparator: Corn oil

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.

Dietary Supplement: Corn oil

Corn oil

Outcome Measures

Primary Outcome Measures

Incidence of chemotherapy induced peripheral neuropathy (CIPN) 8 months after start of adjuvant chemotherapy [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) [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)
Change in severity of CIPN from baseline to 8 months after start of adjuvant chemotherapy according to the EORCT QLQ-CIPN 20 questionnaire [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Deparment of Oncology, Vejle Hospital	Vejle		Denmark

Sponsors and Collaborators

Vejle Hospital

Investigators

Study Director: Lise Ventzel, MD PHD, medical doctor at Vejle Hospital, University Hospital of southern Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Vejle Hospital

ClinicalTrials.gov Identifier:

NCT05404230

Other Study ID Numbers:

OxaNeuro

First Posted:

Jun 3, 2022

Last Update Posted:

Aug 9, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Peripheral Nervous System Diseases

Study Results

No Results Posted as of Aug 9, 2022