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

Primary Purpose

Cancer Cachexia, Side Effects, Quality of Life

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Fish Oil
Placebo
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer Cachexia focused on measuring cancer, nutrition, fish oil

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Departmen of Oncology, Rigshospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Fish oil

Arm Description

Nutritional supplement without fish oil

Nutritional supplement with fish oil

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 23, 2020
Last Updated
January 6, 2021
Sponsor
University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT04699760
Brief Title
The Effects of n-3 LCPUFAs in Patients With Colorectal Cancer
Official Title
Single-blinded, Randomized, Controlled Trial About the Effects of n-3 LCPUFAs on Weight and Functional Status in Patients With Colorectal Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Cachexia, Side Effects, Quality of Life
Keywords
cancer, nutrition, fish oil

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Nutritional supplement without fish oil
Arm Title
Fish oil
Arm Type
Active Comparator
Arm Description
Nutritional supplement with fish oil
Intervention Type
Dietary Supplement
Intervention Name(s)
Fish Oil
Other Intervention Name(s)
Smart Fish - cancer cachexia
Intervention Description
8 weeks, 2.2 G EPA/day
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Weight loss
Description
Difference in weight (kg) from inclusion to 8 week status
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
quality of Life score
Description
score - difference from inclusion to 8 week status (EORTC QLQ-C30 questionnaire)
Time Frame
8 weeks
Title
Performance status - common daily abilities
Description
combined scale - score - ADL
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens R Andersen
Organizational Affiliation
University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Departmen of Oncology, Rigshospital
City
Copenhagen
ZIP/Postal Code
2100 OE
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

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

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