Clinical trial · Interventional
Nutrition Support to Improve Outcomes in Patients With Unresectable Pancreatic Cancer
NCT02681601CI-TRIAL-00060042terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low accrual
Summary
Brief summary (as posted)
There are few well-designed studies evaluating the effect of nutrition support in patients with cancer cachexia. The aim of this study is to examine the effect of dietary prescription with and without nutrition supplementation in patients with unresectable pancreatic cancer on body weight, body composition, total calorie intake, quality of life and blood inflammatory markers.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of Pancreas | Malignant Pancreatic Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diet Only | Other | — | UNRESOLVED |
| Nutrawell Powder | Dietary Supplement | — | UNRESOLVED |
| OmegaRich fish oil supplement | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Diet + Nutrawell Powder with Fish Oil
- description
- Subjects will be evaluated by a registered dietitian with a diet prescription (55% carbohydrate, 30% fat and 15% protein) including Nutrawell powder with fish oil.
- interventionNames
- Dietary Supplement: Nutrawell Powder
- Dietary Supplement: OmegaRich fish oil supplement
- type
- ACTIVE_COMPARATOR
- label
- Dietary Intervention Only
- description
- Subjects will be evaluated by a registered dietitian with a diet prescription (55% carbohydrate, 30% fat and 15% protein) not including servings of Nutrawell powder with fish oil.
- interventionNames
- Other: Diet Only
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Unresectable pancreatic adenocarcinoma * Weight loss of greater than 5% in the previous 6 months * Life expectancy of greater than 3 months and a Karnofsky performance score of 60 or more. * Non-smokers Exclusion Criteria: * Chemotherapy other than gemcitabine * Radiotherapy, or surgical treatment in the previous month * Consumption of dietary supplements or medications such as steroids that could affect metabolism. * Presence of ascites * Liver function test \> 2 standard deviation of upper limit * Chronic or acute renal insufficiency * Severe anemia with hemoglobin\<10 * Uncontrolled pain * Uncontrolled nausea and vomiting * Participation in a therapeutic research study within 30 days of baseline * Diet restrictions including vegetarianism and veganism * Allergy or intolerance to fish and/or fish oil
References
Publications (10)
- BACKGROUNDLillemoe KD. Palliative therapy for pancreatic cancer. Surg Oncol Clin N Am. 1998 Jan;7(1):199-216. PMID 9443996
- BACKGROUNDCapra S, Bauer J, Davidson W, Ash S. Nutritional therapy for cancer-induced weight loss. Nutr Clin Pract. 2002 Aug;17(4):210-3. doi: 10.1177/0115426502017004210. PMID 16214989
- BACKGROUNDStratton RJ. Should food or supplements be used in the community for the treatment of disease-related malnutrition? Proc Nutr Soc. 2005 Aug;64(3):325-33. doi: 10.1079/pns2005439. PMID 16048664
- BACKGROUNDFearon KC, Von Meyenfeldt MF, Moses AG, Van Geenen R, Roy A, Gouma DJ, Giacosa A, Van Gossum A, Bauer J, Barber MD, Aaronson NK, Voss AC, Tisdale MJ. Effect of a protein and energy dense N-3 fatty acid enriched oral supplement on loss of weight and lean tissue in cancer cachexia: a randomised double blind trial. Gut. 2003 Oct;52(10):1479-86. doi: 10.1136/gut.52.10.1479. PMID 12970142
- BACKGROUNDCawood AL, Elia M, Stratton RJ. Systematic review and meta-analysis of the effects of high protein oral nutritional supplements. Ageing Res Rev. 2012 Apr;11(2):278-96. doi: 10.1016/j.arr.2011.12.008. Epub 2011 Dec 22. PMID 22212388
- BACKGROUNDGoldberg MF, Custis PH. Retinal and other manifestations of incontinentia pigmenti (Bloch-Sulzberger syndrome). Ophthalmology. 1993 Nov;100(11):1645-54. doi: 10.1016/s0161-6420(93)31422-3. PMID 8233390
- BACKGROUNDKraft M, Kraft K, Gartner S, Mayerle J, Simon P, Weber E, Schutte K, Stieler J, Koula-Jenik H, Holzhauer P, Grober U, Engel G, Muller C, Feng YS, Aghdassi A, Nitsche C, Malfertheiner P, Patrzyk M, Kohlmann T, Lerch MM. L-Carnitine-supplementation in advanced pancreatic cancer (CARPAN)--a randomized multicentre trial. Nutr J. 2012 Jul 23;11:52. doi: 10.1186/1475-2891-11-52.