Clinical trial NCT05404230: Prevention of Oxaliplatin-induced Nerve Damage in the Body's Extremities
Official title: Prevention of Oxaliplatin-induced Peripheral Neuropathy - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peripheral Neuropathy
Colorectal Cancer
Lead sponsor: Vejle Hospital
Sponsor class: OTHER
First posted: 2022-06-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Incidence of chemotherapy induced peripheral neuropathy (CIPN) 8 months after start of adjuvant chemotherapy
timeFrame: 8 months after start of adjuvant chemotherapy
Secondary outcomes:
measure: Intensity of CIPN-related neuropathic pain 8 months after adjuvant chemotherapy according to the Numeric Rating Scale (NRS)
timeFrame: 8 months after start of adjuvant chemotherapy
measure: Change in severity of CIPN from baseline to 8 months after start of adjuvant chemotherapy according to the EORCT QLQ-CIPN 20 questionnaire
timeFrame: 8 months after start of adjuvant chemotherapy
Other outcomes:
Locations:
city: Vejle
country: Denmark
facility: Deparment of Oncology, Vejle Hospital
Study officials:
affiliation: medical doctor at Vejle Hospital, University Hospital of southern Denmark
name: Lise Ventzel, MD PHD
role: STUDY_DIRECTOR
References: