NCT01423799

Brief Summary

The purpose of this study is to compare the health-related quality of life following dietary supplementation with an immunonutrition formulation vs an isocaloric/isoprotein control diet supplement in patients suffering from upper digestive tract neoplasia undergoing oncological treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2012

Typical duration for phase_3

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

First Submitted

Initial submission to the registry

August 24, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 26, 2011

Completed
10 months until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

November 13, 2015

Status Verified

November 1, 2015

Enrollment Period

3.3 years

First QC Date

August 24, 2011

Last Update Submit

November 11, 2015

Conditions

Gastrointestinal Cancer

Keywords

Quality of lifeCancerImmunonutrition

Outcome Measures

Primary Outcomes (1)

  • Quality of Life (QOL), measured with the EORTC QLQ-C30

    QOL will me measured 30 days post-surgery

Secondary Outcomes (1)

  • QOL assessed by the EORTC QLQ-OG 25

    QOL will me measured 30 days post-surgery

Study Arms (2)

Nutritional product

EXPERIMENTAL

Nutritional intervention containing immuno-nutrients

Dietary Supplement: Nutritional supplements containing arginine, n-3 and nucleotides

Control Group

ACTIVE COMPARATOR

Isocaloric and isonitrogenous control without immuno nutrients.

Dietary Supplement: Isocaloric control

Interventions

Nutritional supplements containing arginine, n-3 and nucleotidesDIETARY_SUPPLEMENT

Nutritional intervention with immuno-nutrients

Nutritional product
Isocaloric controlDIETARY_SUPPLEMENT

Isocaloric and isonitrogenous control without immuno nutrients

Control Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically proven GI cancer.
  • Age ≥ 18 years.
  • Life expectancy more than 3 months.
  • Female patients of child-bearing potential must be willing to employ effective contraception during the study period.
  • Female patients of child-bearing potential must have a negative serum Beta Human Chorionic Gonadotrophin (βhCG) test at Visit 0.
  • The patient is able to communicate effectively with study personnel and is considered reliable, willing, and cooperative in terms of compliance with the protocol requirements.
  • The patient voluntarily gives written informed consent to participate in the study.

You may not qualify if:

  • Severe concomitant clinical conditions other than the previously untreated digestive tract cancer that jeopardise the protocol follow-up.
  • The patient is pregnant or is a lactating woman.
  • Currently participating or having participated in another interventional clinical trial related to nutritional support during the 30 days prior to the beginning of the study product intake, except if this other interventional trial is testing new drug or surgical intervention. (Note: participation in a prior or concurrent clinical trial not related to nutritional support does not exclude the patient from participation.)
  • Other malignancies in the last 5 years (except for successfully treated in situ basocellular skin and in situ cervical uterine tumours).
  • Patients with more than 20% weight loss over a 6 months period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Régional Universitaire de Lille

Lille, 59037, France

Location

MeSH Terms

Conditions

Gastrointestinal NeoplasmsNeoplasms

Interventions

Nucleotides

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

GlycosidesCarbohydratesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Christophe Mariette, MD

    University Hospital Claude Huriez, CHRU-Place de Verdun-59037 Lille, Cedex France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2011

First Posted

August 26, 2011

Study Start

July 1, 2012

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

November 13, 2015

Record last verified: 2015-11

Locations

FR(1)