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Study to Assess the Effectiveness of a Omega-3 Enriched Supplement on Chemotherapy Tolerance in Colon Cancer Patients

Primary Purpose

Colorectal Neoplasms

Status
Terminated
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Eicosapentaenoic acid enriched nutritional supplement
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colorectal Neoplasms focused on measuring Colorectal Neoplasms, Eicosapentaenoic Acid, Quality of Life, Nutritional Status

Eligibility Criteria

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

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Hospital Clinic of Barcelona

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Eicosapentaenoic acid enriched nutritional supplement

No supplementation

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

To assess the influence of the nutritional status over the tolerance to the antineoplastic treatment.
To assess the effect of a nutritional supplement over the nutritional status of the patient with disseminated neoplastic illness.

Full Information

First Posted
November 9, 2006
Last Updated
June 19, 2013
Sponsor
Hospital Clinic of Barcelona
Collaborators
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00398333
Brief Title
Study to Assess the Effectiveness of a Omega-3 Enriched Supplement on Chemotherapy Tolerance in Colon Cancer Patients
Official Title
Randomized Controlled, Open-label, Pilot Study to Assess the Effectiveness of a Nutritional Supplementation Enriched With Eicosapentaenoic Acid on Chemotherapy Tolerance in Patients With Advanced Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Terminated
Why Stopped
Impossibility to accomplish the sample size in assigned time.
Study Start Date
June 2005 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona
Collaborators
Abbott

4. Oversight

5. Study Description

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.
Detailed Description
Colorectal cancer is one of the main causes of mortality in western countries. It is considered that in case of colorectal carcinoma, the frequency of weight loss at the moment of diagnosis is 54%. Undernourishment affects negatively the course of the illness and it confers a worse prognostic, increasing the morbidity and the mortality, while it entails an impairment in the quality of life of the patient. There is a narrow relationship in the oncologic pathology between undernourishment and the pathology itself, drawing a common syndrome called cancerous cachexia. It is usual that patients subjected to chemotherapy present nutritional alterations due to the treatments' side effects. With this study we want to assess the efficacy of a nutritional intervention with supplementation enriched in EPA to improve the tolerance to the antineoplastic treatment. As an index of tolerability to the chemotherapy treatment, it will be used the variation of changes in quality of life evaluated through the questionnaire EORTC QLQ-C30, using the parameters of global quality of life and physical function.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
Keywords
Colorectal Neoplasms, Eicosapentaenoic Acid, Quality of Life, Nutritional Status

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Eicosapentaenoic acid enriched nutritional supplement
Arm Type
Experimental
Arm Title
No supplementation
Arm Type
No Intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Eicosapentaenoic acid enriched nutritional supplement
Other Intervention Name(s)
Prosure
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
To assess the influence of the nutritional status over the tolerance to the antineoplastic treatment.
Time Frame
6 months
Title
To assess the effect of a nutritional supplement over the nutritional status of the patient with disseminated neoplastic illness.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pere Leyes, MD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clinic of Barcelona
City
Barcelona
State/Province
Catalonia
ZIP/Postal Code
08036
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
21336429
Citation
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.
Results Reference
result

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Study to Assess the Effectiveness of a Omega-3 Enriched Supplement on Chemotherapy Tolerance in Colon Cancer Patients

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