EPA Supplementation in Cancer Patients Receiving Abdominal Radiotherapy -

NCT ID: NCT04687124

Last Updated: 2020-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-15

Study Completion Date

2021-02-28

Brief Summary

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Malnutrition occurs frequently in patients with cancer during and after radiotherapy to the gastrointestinal (GI) area and can lead to negative outcomes. N-3 fatty acids from fish, especially eicosapentaenoic acid (EPA) may possess anticachectic properties. The aim of this study is to investigate the effect of two nutritional interventions; dietary counselling and an oral nutritional supplement (ONS) containing 2.2 g of the n-3 fatty acid EPA (Forticare®) or standard care, including dietary counselling and protein supplementation when needed.

Detailed Description

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Methods: Outpatients commencing radiotherapy to the GI area due to dissiminated cancer are randomized to receive dietary counselling and daily fish-oil supplementation over a 5-7 week period, or standard care. Outcome parameters are measured at baseline (onset of radiotherapy), week 5, and 12 weeks after commencing radiotherapy, with one additional measurement of body weight at week 2. Quality of life (QoL) is measured using the EORTC QLQ-C30 questionnaire. Radiotherapy-related side effects are assessed using a questionnaire developed specifically for this study. Data from a historical control group collected in a previous observational study is included in this study to compare incidence of weight loss.

Conditions

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Abdominal Cancer Radiotherapy; Complications Weight Loss Energy Supply Protein Deficiency

Keywords

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Malnutrition radiotherapy, oral nutritional supplements fish-oil

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomization by sealed envelopes. Stratified for location of cancer
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fish oil

dietary counselling including an oral nutritional supplement (ONS) containing 2.2 g of n-3 fatty acid EPA (Forticare®)

Group Type ACTIVE_COMPARATOR

Fish oil

Intervention Type DIETARY_SUPPLEMENT

Dietary counseling including an oral nutritional supplement (ONS) containing 2.2 g of n-3 fatty acid EPA (Forticare®)

standard care

The departmental usual procedure with the possibility of requiring of a dietician when needed

Group Type PLACEBO_COMPARATOR

standard care

Intervention Type OTHER

No specified intervention

Interventions

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Fish oil

Dietary counseling including an oral nutritional supplement (ONS) containing 2.2 g of n-3 fatty acid EPA (Forticare®)

Intervention Type DIETARY_SUPPLEMENT

standard care

No specified intervention

Intervention Type OTHER

Other Intervention Names

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Dietary counseling

Eligibility Criteria

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Inclusion Criteria

* referred to radiotherapy for dissminated, abdominal cancer
* \> 18 years of age
* able to understand and comply with the intervention
* willingness to participate after oral and written conscent

Exclusion Criteria

* conditions precluding evaluations of end-points
* dementia
* operations planned in the observation period
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Department of Oncology, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen

UNKNOWN

Sponsor Role collaborator

Jens Rikardt Andersen

OTHER

Sponsor Role lead

Responsible Party

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Jens Rikardt Andersen

Sponsor - Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Department of Oncology, Rigshospitalet

Copenhagen, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Jens R Andersen, MD,MPA

Role: CONTACT

Phone: +4523346654

Email: [email protected]

Poula Patursson, MSc, RD

Role: CONTACT

Phone: +298 224 112

Email: [email protected]

Facility Contacts

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Jens R Andersen

Role: primary

Grith Møller

Role: backup

References

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Patursson P, Moller G, Muhic A, Andersen JR. N-3 fatty acid EPA supplementation in cancer patients receiving abdominal radiotherapy - A randomised controlled trial. Clin Nutr ESPEN. 2021 Jun;43:130-136. doi: 10.1016/j.clnesp.2021.03.001. Epub 2021 Mar 16.

Reference Type DERIVED
PMID: 34024504 (View on PubMed)

Other Identifiers

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H-D-2007-0134

Identifier Type: -

Identifier Source: org_study_id