NCT04699760

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2015

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

December 23, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 7, 2021

Completed
Last Updated

January 7, 2021

Status Verified

January 1, 2021

Enrollment Period

5 months

First QC Date

December 23, 2020

Last Update Submit

January 6, 2021

Conditions

Cancer CachexiaSide EffectsQuality of Life

Keywords

cancernutritionfish oil

Outcome Measures

Primary Outcomes (1)

  • Weight loss

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

    8 weeks

Secondary Outcomes (2)

  • quality of Life score

    8 weeks

  • Performance status - common daily abilities

    8 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Nutritional supplement without fish oil

Dietary Supplement: Placebo

Fish oil

ACTIVE COMPARATOR

Nutritional supplement with fish oil

Dietary Supplement: Fish Oil

Interventions

Fish OilDIETARY_SUPPLEMENT

8 weeks, 2.2 G EPA/day

Also known as: Smart Fish - cancer cachexia
Fish oil
PlaceboDIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \< 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departmen of Oncology, Rigshospital

Copenhagen, 2100 OE, Denmark

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Fish Oils

Intervention Hierarchy (Ancestors)

OilsLipids

Study Officials

  • Jens R Andersen

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 23, 2020

First Posted

January 7, 2021

Study Start

April 1, 2015

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

January 7, 2021

Record last verified: 2021-01

Locations

DK(1)