Condition category
Cancer
Date applied
11/05/2011
Date assigned
10/06/2011
Last edited
10/06/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ate Van der Gaast

ORCID ID

Contact details

S-Gravendijkwal 230
Rotterdam
3015 CE
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Onc. 2.C/C

Study information

Scientific title

NUtritional Support in Patients with newly diagnosed oEsophageal Cancer: a randomised, double blind, controlled clinical trial

Acronym

NUSPEC

Study hypothesis

The active sip feed is expected to beneficially change pre-treatment immune function in patients with newly diagnosed cancer of the oesophagus compared to routine nutritional support.

Ethics approval

Medical Ethics Committee of the Erasmus (Medisch Ethische Toetsings Commissie Erasmus MC), Rotterdam, Netherlands approved on 14th June 2007, reference number: MEC-2007-109

Study design

Randomised double blind controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

Oesophageal cancer

Intervention

Duration of intervention: 4 weeks pre-treatment

Active products: Nutritionally complete oral supplement, high in protein and leucine and enriched with fish oil, specific oligosaccharides and a balanced mix of vitamins, minerals and trace elements.

Active products:
1. Body weight loss in past 3 months is 0 to < 5% or weight gain and dysphagia score is 0 or 1: Active sip feed (2 x 200 mL daily)
2. Body weight loss in past 3 months 5% or more and/or dysphagia score 2 or 3 and/or patients using/prescribed sip feed in the last 4 weeks: Active sip feed (at least 2 x 200 mL daily)

Control products: The control product is either a non-caloric placebo product or an iso-caloric standard nutritional product, both without fish oil enrichment or specific oligosaccharides.

Routine Care (Control products):
1. Body weight loss in past 3 months is 0 to < 5% or weight gain and dysphagia score 0 or 1:Placebo sip feed (2 x 200 mL daily)
2. Body weight loss in past 3 months 5% or more and/or dysphagia score 2 or 3 and/or patients using/prescribed sip feed in the last 4 weeks: iso-caloric control sip feed (at least 2 x 200 mL daily)

Intervention type

Drug

Phase

Not Applicable

Drug names

Nutritional feeds

Primary outcome measures

To assess the effects of the Active sip feed on pre-treatment immune function in patients with newly diagnosed cancer of the oesophagus and to compare this with the effects of routine nutritional support.

Immune function was measured by the ex vivo production of Th1/Th2 cytokines in ConA stimulated peripheral blood mononuclear cells (PBMC) and production of inflammatory cytokines and prostaglandin E2 (PGE2) in lipopolysaccharides (LPS)-stimulated PBMC, both at visit 1 and visit 3. Cytokines were measured by Bio-Plex assay and PGE2 by enzyme immunoassay (EIA).

Secondary outcome measures

1. To assess the effects of the Active sip feed on pre-treatment nutritional status in patients with newly diagnosed cancer of the oesophagus and to compare this with the effects of routine nutritional support.
2. To obtain exploratory information on immune function and nutritional status post-surgery
3. To obtain data on immune and nutritional parameters in healthy volunteers to allow for adequate interpretation of the data from patients

Overall trial start date

01/08/2007

Overall trial end date

01/02/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Patients:
1. Newly diagnosed with carcinoma of the oesophagus or gastro-oesophageal junction (Siewert-Stein classification type I - III)
2. Age more than or equal to 18 years
3. Written informed consent

Reference group (were included for baseline comparisons, no intervention in these subjects):
1. Age and sex-matched with the Dutch oesophagus cancer population
2. Written informed consent
3. Body mass index (BMI) 18.5-30 kg/m2

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

67

Participant exclusion criteria

Patients:
1. Life expectancy < 3 months
2. Planned start of cancer treatment within 3 weeks
3. Eastern Cooperative Oncology Group (ECOG) performance status > 2
4. Any oesophagus related surgery after diagnosis before inclusion
5. Chemo- and/or radiotherapy in the past 5 years
6. Altered immune function [e.g. caused by major active infection, autoimmune disease, active allergy, rheumatoid arthritis, inflammatory bowel diseases, multiple sclerosis, or by use of medication such as immunosuppressive drugs, immunomodulators, or corticosteroids (unless not considered to be systemically available)]
7. Dysphagia score of 4 using the dysphagia scoring system
8. Dependence on tube feed or parenteral nutrition in the last 4 weeks
9. Use of fish oil containing supplements during the last 4 weeks
10. Intolerance or allergy to dairy, fish, or other ingredients of the study products
11. Dependency on fibre free diet
12. If pre-menopausal female: pregnant or lactating
13. Dementia or altered mental status that would prohibit the understanding and giving of informed consent
14. Any other medical condition that may interfere with the safety of the patient or the outcome parameters, in the investigator’s judgment.
15. Investigator’s uncertainty about the willingness or ability of the patient to comply with the protocol requirements (e.g. alcohol abuse)

Reference group (were included for baseline comparisons, no intervention in these subjects):
1. Significant involuntary weight loss in the past year
2. Smoking (defined as currently smoking or quit less than or equal to 6 months ago)
3. Acute or chronic disease
4. Altered immune function [e.g. caused by major active infection, autoimmune disease, active allergy, rheumatoid arthritis, inflammatory bowel diseases, multiple sclerosis, or by use of medication such as immunosuppressive drugs, immunomodulators, or corticosteroids (unless not considered to be systemically available)]
5. If pre-menopausal female: pregnant or lactating
6. Any other condition that may interfere with the definition ‘healthy volunteer’ according to the investigator’s judgement

Recruitment start date

01/08/2007

Recruitment end date

01/02/2009

Locations

Countries of recruitment

Netherlands

Trial participating centre

S-Gravendijkwal 230
Rotterdam
3015 CE
Netherlands

Sponsor information

Organisation

Danone Research (Netherlands)

Sponsor details

Bosrandweg 20
Wageningen
6704 PH
Netherlands
+31 (0)317 467 800
joyce.faber@danone.com

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Danone Research (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes