NUtritional Support in Patients with newly diagnosed oEsophageal Cancer
| ISRCTN | ISRCTN28490479 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28490479 |
| Secondary identifying numbers | Onc. 2.C/C |
- 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
Scientific
S-Gravendijkwal 230
Rotterdam
3015 CE
Netherlands
Study information
| Study design | Randomised double blind controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| Scientific title | NUtritional Support in Patients with newly diagnosed oEsophageal Cancer: a randomised, double blind, controlled clinical trial |
| Study acronym | NUSPEC |
| Study objectives | 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(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) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Nutritional feeds |
| Primary outcome measure | 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 study start date | 01/08/2007 |
| Completion date | 01/02/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 67 |
| Key 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 |
| Key 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 investigators judgment. 15. Investigators 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 investigators judgement |
| Date of first enrolment | 01/08/2007 |
| Date of final enrolment | 01/02/2009 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
S-Gravendijkwal 230
Rotterdam
3015 CE
Netherlands
3015 CE
Netherlands
Sponsor information
Danone Research (Netherlands)
Industry
Industry
Bosrandweg 20
Wageningen
6704 PH
Netherlands
| Phone | +31 (0)317 467 800 |
|---|---|
| joyce.faber@danone.com | |
"ROR" |
https://ror.org/01c5aqt35 |
Funders
Funder type
Industry
Danone Research (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
