The Effects of n-3 LCPUFAs in Patients With Colorectal Ca... | NCT04699760

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

NCT04699760

Sponsor

University of Copenhagen

Status

Completed

Last Update Posted

Jan 7, 2021Actual

Enrollment

50Actual

Phase

Phase 4

Conditions

Cancer Cachexia
Side Effects
Quality of Life

Interventions

Fish Oil
Placebo

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2015

Primary Completion Date

Sep 2015Actual

Completion Date

Sep 2015Actual

First Submitted Date

Dec 23, 2020

First Submission Date that Met QC Criteria

Jan 6, 2021

First Posted Date

Jan 7, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 6, 2021

Last Update Posted Date

Jan 7, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Fish Oil	Dietary Supplement	8 weeks, 2.2 G EPA/day	Fish oil	Smart Fish - cancer cachexia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Weight loss	Difference in weight (kg) from inclusion to 8 week status	8 weeks

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jens R Andersen	University of Copenhagen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Departmen of Oncology, Rigshospital		Copenhagen		2100 OE	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D009821	Oils
D008055	Lipids