NUtritional Support in Patients with newly diagnosed oEsophageal Cancer

ISRCTN ISRCTN28490479
DOI https://doi.org/10.1186/ISRCTN28490479
Protocol serial number Onc. 2.C/C
Sponsor Danone Research (Netherlands)
Funder Danone Research (Netherlands)
Submission date
11/05/2011
Registration date
10/06/2011
Last edited
10/06/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Ate Van der Gaast
Scientific

S-Gravendijkwal 230
Rotterdam
3015 CE
Netherlands

Study information

Primary study designInterventional
Study designRandomised double blind controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleNUtritional Support in Patients with newly diagnosed oEsophageal Cancer: a randomised, double blind, controlled clinical trial
Study acronymNUSPEC
Study objectivesThe 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(s)Medical Ethics Committee of the Erasmus (Medisch Ethische Toetsings Commissie Erasmus MC), Rotterdam, Netherlands approved on 14th June 2007, reference number: MEC-2007-109
Health condition(s) or problem(s) studiedOesophageal cancer
InterventionDuration 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 typeDrug
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Nutritional feeds
Primary outcome measure(s)

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).

Key secondary outcome measure(s)

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

Completion date01/02/2009

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration67
Key inclusion criteriaPatients:
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
Key exclusion criteriaPatients:
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
Date of first enrolment01/08/2007
Date of final enrolment01/02/2009

Locations

Countries of recruitment

  • Netherlands

Study participating centre

S-Gravendijkwal 230
Rotterdam
3015 CE
Netherlands

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
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