The Effects of n-3 LCPUFAs in Patients With Colorectal Cancer

Phase 4

Completed

• Conditions: Quality of Life; Cancer Cachexia; Side Effects
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Fish Oil

• Registration Number: NCT04699760
• Lead Sponsor: University of Copenhagen

Brief Summary

The aim of this study is to determine the effects of n-3 PUFAs on weight, physical funktion and quality of life in patients with colorectal cancer.

Detailed Description

Primary outcomes:

* Weight

* Physical function

* Hand-grip strength

Secondary outcomes:

* Quality of life

* Mid-upperarm circumference

* Incorporation of n-3 PUFAs into cell membranes

Study Timeline

• Study Start: 2015-04
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Study First Submitted: 2020-12-23
• Status Verified: 2021-01
• Study First Submitted QC: 2021-01-06
• Last Update Submitted: 2021-01-06
• Study First Posted: 2021-01-07
• Last Update Posted: 2021-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• ≥18 years
• Patients with diagnosed colorectal cancer with metastases treated with chemotherapy on Rigshospitalet, Copenhagen

Exclusion Criteria

• < 18 years
• Patients in palliative care
• patients with haemophilia
• Patiens in treatment of anti-coagulation
• Patients with genetic hyperkolesterolemia
• Pre-dialytic patients (GFR<15ml/min/1,73m2 eller kreatinin ≥500 mmol/L)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Nutritional supplement without fish oil
Fish oil	Fish Oil	Nutritional supplement with fish oil

Primary Outcome Measures

Name	Time	Method
Weight loss	8 weeks	Difference in weight (kg) from inclusion to 8 week status

Secondary Outcome Measures

Name	Time	Method
Performance status - common daily abilities	8 weeks	combined scale - score - ADL
quality of Life score	8 weeks	score - difference from inclusion to 8 week status (EORTC QLQ-C30 questionnaire)

Trial Locations

Locations (1)

Departmen of Oncology, Rigshospital; 🇩🇰 Copenhagen, Denmark