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Completed

NCT Number: NCT04699760

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

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.

Completed

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Key information

Conditions

Cancer Cachexia Neoplasms Quality of Life Side Effects

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Departmen of Oncology, Rigshospital

Copenhagen, 2100 OE, Denmark

About this study

Primary outcomes:

  • Weight
  • Physical function
  • Hand-grip strength

Secondary outcomes:

  • Quality of life
  • Mid-upperarm circumference
  • Incorporation of n-3 PUFAs into cell membranes

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Fish Oil

Dietary Supplement

8 weeks, 2.2 G EPA/day

Other names: Smart Fish - cancer cachexia

Placebo

Dietary Supplement

Placebo

Primary outcomes

  1. Weight loss

    Time frame: 8 weeks

    Difference in weight (kg) from inclusion to 8 week status

Secondary outcomes

  1. quality of Life score

    Time frame: 8 weeks

    score - difference from inclusion to 8 week status (EORTC QLQ-C30 questionnaire)

  2. Performance status - common daily abilities

    Time frame: 8 weeks

    combined scale - score - ADL

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jan 7, 2021
Registry last updated
Jan 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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