Clinical trial · Observational
Nutritional Status in Locally Advanced or Metastatic Solid Cancer Patients in Spain: the NutriOncoSearch (NOS) Study
An Observational Study of the Nutritional Status in Locally Advanced or Metastatic Solid Cancer Patients While Receiving Immunotherapy in Spain: the NutriOncoSearch (NOS) Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Malnutrition is a common medical problem in oncology patients. It is well known that the presence of malnutrition negatively affects patients' evolution and their quality of life, increasing the incidence of infection, hospital stay, and mortality. The new knowledge of cancer biology has made it possible to know the mechanisms of cancer progression. New treatments have been developed thanks to this knowledge including molecular target treatments aimed at these cancer mechanics and to reverse the antitumor capacity of the immune system. However, these treatments have different toxicities than classic and anachronistic treatments such as chemotherapy and radiotherapy, including alterations in glucose metabolism, endocrinopathies, rhabdomyolysis, etc. that can alter both the patient's nutritional status and quality of life. Additionally, a deficient nutritional status can have an impact on the intestinal microbiota, compromising the efficacy of the new antitumor treatments. The principal objective of this study is to characterize the nutritional status of the cancer outpatient receiving immunotherapy through a screening performed in Hospital consultations in Spain. Secondary Endpoints are (a). To describe the percentage of patients that receive nutritional counseling or nutritional support (enteral and/or parenteral nutrition) among those diagnosed as malnourished or at risk. And (b) to categorize the percentage and descriptive characteristics of cancer patients with mild, moderate, or severe malnutrition that goes to a hospital consultation in Spain and describe the percentage and descriptive characteristics of patients with malnutrition according to sociodemographic and clinical characteristics.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malnutrition | — | UNRESOLVED | — |
| Oncologic Complications | — | UNRESOLVED | — |
| Oncology | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Observational test | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Oncology patients (Immunotherapy alone or in combination))
- description
- 1. Outpatients, over 18 years old, with locally advanced or metastatic solid tumors (with the idea of homogenizing the sample as far as possible and in line with what has been published up to now, also stratified in line with Globocan). 2. Patients under targeted active treatment either exclusively or in combination with chemotherapy or radiotherapy. Targeted therapy (immunotherapy) defined with: PD1, PDL1 inhibitors. At least 12 weeks of treatment.
- interventionNames
- Other: Observational test
- label
- Oncology Patients (Chemo-Radiotherapy group).
- description
- 1. Outpatients, over 18 years old, with locally advanced or metastatic solid tumors (with the idea of homogenizing the sample as far as possible and in line with what has been published up to now, also stratified in line with Globocan). 2. Patients under active treatment either in combination with chemotherapy or radiotherapy. At least 12 weeks of treatment.
- interventionNames
- Other: Observational test
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Outpatients, over 18 years old, with locally advanced or metastatic solid tumors (with the idea of homogenizing the sample as far as possible and in line with what has been published up to now, also stratified in line with Globocan). 2. Patients under immunotherapy treatment either exclusively or in combination with chemotherapy or radiotherapy. Immunotherapy defined by checkpoint treatments inhibitors PD-1, PDL-1 y CTLA-4. At least 12 weeks of treatment. Key Exclusion Criteria: 1. Estimated survival below 12 weeks (palliative criteria). 2. Patients that meet diagnostic criteria (DSM-IV and ICD-10) of nervous anorexia and bulimia. 3. Patients with severe psychiatric disorders.
References
Publications (9)
- BACKGROUNDde Las Penas R, Majem M, Perez-Altozano J, Virizuela JA, Cancer E, Diz P, Donnay O, Hurtado A, Jimenez-Fonseca P, Ocon MJ. SEOM clinical guidelines on nutrition in cancer patients (2018). Clin Transl Oncol. 2019 Jan;21(1):87-93. doi: 10.1007/s12094-018-02009-3. Epub 2019 Jan 8. PMID 30617923
- BACKGROUNDArribas L, Hurtos L, Sendros MJ, Peiro I, Salleras N, Fort E, Sanchez-Migallon JM. NUTRISCORE: A new nutritional screening tool for oncological outpatients. Nutrition. 2017 Jan;33:297-303. doi: 10.1016/j.nut.2016.07.015. Epub 2016 Aug 13. PMID 27751743
- BACKGROUNDHanahan D, Weinberg RA. Hallmarks of cancer: the next generation. Cell. 2011 Mar 4;144(5):646-74. doi: 10.1016/j.cell.2011.02.013. PMID 21376230
- BACKGROUNDEscortell Sanchez R, Reig Garcia-Galbis M. [ENTERAL NUTRITION ON THE NUTRITIONAL STATUS OF CANCER]. Nutr Hosp. 2015 Oct 1;32(4):1408-16. doi: 10.3305/nh.2015.32.4.9227. Spanish. PMID 26545500
- BACKGROUNDGomez-Candela C, Luengo LM, Cos AI, Martinez-Roque V, Iglesias C, Zamora P, Gonzalez-Baron R. [Subjective global assessment in neoplastic patients]. Nutr Hosp. 2003 Nov-Dec;18(6):353-7. Spanish. PMID 14682183
- RESULTHebuterne X, Lemarie E, Michallet M, de Montreuil CB, Schneider SM, Goldwasser F. Prevalence of malnutrition and current use of nutrition support in patients with cancer. JPEN J Parenter Enteral Nutr. 2014 Feb;38(2):196-204. doi: 10.1177/0148607113502674. PMID 24748626
- RESULTSegura A, Pardo J, Jara C, Zugazabeitia L, Carulla J, de Las Penas R, Garcia-Cabrera E, Luz Azuara M, Casado J, Gomez-Candela C. An epidemiological evaluation of the prevalence of malnutrition in Spanish patients with locally advanced or metastatic cancer. Clin Nutr. 2005 Oct;24(5):801-14. doi: 10.1016/j.clnu.2005.05.001.