NCT00398333

Brief Summary

The purpose of this study is to determine if a nutritional supplement enriched in omega-3 fatty acids is effective in improving the tolerance to chemotherapy treatment and improves quality of life.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2005

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

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

June 1, 2005

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 10, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

June 20, 2013

Status Verified

June 1, 2013

Enrollment Period

2.8 years

First QC Date

November 9, 2006

Last Update Submit

June 19, 2013

Conditions

Colorectal Neoplasms

Keywords

Colorectal NeoplasmsEicosapentaenoic AcidQuality of LifeNutritional Status

Outcome Measures

Primary Outcomes (1)

  • To assess the efficacy of a nutritional intervention with supplementation enriched in EPA to improve the tolerance to the antineoplastic treatment, using the variation in quality of life changes as the tolerability index.

    3 months

Secondary Outcomes (2)

  • To assess the influence of the nutritional status over the tolerance to the antineoplastic treatment.

    6 months

  • To assess the effect of a nutritional supplement over the nutritional status of the patient with disseminated neoplastic illness.

    3 months

Study Arms (2)

Eicosapentaenoic acid enriched nutritional supplement

EXPERIMENTAL
Dietary Supplement: Eicosapentaenoic acid enriched nutritional supplement

No supplementation

NO INTERVENTION

Interventions

Eicosapentaenoic acid enriched nutritional supplementDIETARY_SUPPLEMENT

Oral intake of nutritional supplementation: a maximum of 480 mL or a minimum of 240 mL daily during the first 3 months of the study.

Also known as: Prosure
Eicosapentaenoic acid enriched nutritional supplement

Eligibility Criteria

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

You may qualify if:

  • Patients diagnosed of metastatic colon adenocarcinoma that are going to receive first line chemotherapy treatment in the oncology day hospital.
  • Age over 18 years old.

You may not qualify if:

  • Patients diagnosed of colon cancer are receiving second line chemotherapy.
  • Antecedents of other malignant tumors with the exception of basocellular epithelioma.
  • Chronic renal failure (Creatinine \> 1.7).
  • Previous diabetes mellitus.
  • Obesity (IMC \> 30)
  • Medical conditions that imply hepatic encephalopathy, or ascites.
  • Severe malnutrition according to the classification of the Subjective Global Assessment (SGA) or a BMI \< 16.5.
  • Major psychiatric disorder.
  • Patients receiving enteral or parenteral nutrition.
  • Contraindications for the indication of the nutritional supplement: Galactosemia.
  • Seafood or seafood byproducts allergy.
  • Patients taking drugs that affect the metabolism (anabolic steroids, orexigenic agents...).
  • Absence of the informed consent form signed by the patient.
  • Any patient who has disability to comply with the treatment or who has inability according to the researcher.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinic of Barcelona

Barcelona, Catalonia, 08036, Spain

Location

Related Publications (1)

  • Trabal J, Leyes P, Forga M, Maurel J. Potential usefulness of an EPA-enriched nutritional supplement on chemotherapy tolerability in cancer patients without overt malnutrition. Nutr Hosp. 2010 Sep-Oct;25(5):736-40.

    PMID: 21336429RESULT

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Pere Leyes, MD

    Hospital Clinic of Barcelona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist

Study Record Dates

First Submitted

November 9, 2006

First Posted

November 10, 2006

Study Start

June 1, 2005

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

June 20, 2013

Record last verified: 2013-06

Locations

ES(1)