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NCT04699760 Clinical Trial

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

Quality of Life Clinical Trial

Official title:
Single-blinded, Randomized, Controlled Trial About the Effects of n-3 LCPUFAs on Weight and Functional Status in Patients With Colorectal Cancer.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04699760
Other study ID # H-4-2014-131
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date April 2015
Est. completion date September 2015

Study information
Verified date January 2021
Source University of Copenhagen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date September 2015
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Fish Oil
8 weeks, 2.2 G EPA/day
• Placebo
Placebo

Locations
Country Name City State
Denmark Departmen of Oncology, Rigshospital Copenhagen

Sponsors (1)
Lead Sponsor Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Weight loss Difference in weight (kg) from inclusion to 8 week status 8 weeks
Secondary quality of Life score score - difference from inclusion to 8 week status (EORTC QLQ-C30 questionnaire) 8 weeks
Secondary Performance status - common daily abilities combined scale - score - ADL 8 weeks
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