Nutritional Status in Locally Advanced or Metastatic Solid Cancer Patients in Spain: the NutriOncoSearch (NOS) Study

NCT04168814 | Completed

• 1 other identifier: SEEO-19-01-NOS
• Study Type: observational
• Target: 586
• Locations: 1 country
• Sites: 11

Brief Summary

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

Malnutrition; Oncologic Complications; Oncology; Quality of Life

Keywords

Nutritional status; Oncology Patients; Anticancer treatments; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Nutritional status

  To characterize the nutritional status of the cancer outpatient receiving either immunotherapies or any other targeted therapies through a screening performed in Hospital consultations in Spain.

  Six months

Secondary Outcomes (2)

• Nutritional counselling

  Six months

• Descriptive characteristic mild, moderate or severe malnutrition

  Six months

Study Arms (2)

Oncology patients (Immunotherapy alone or in combination))

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.

Other: Observational test

Oncology Patients (Chemo-Radiotherapy group).

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.

Other: Observational test

Interventions

Observational test OTHER

Nutritional risk (NutriScore), based on weight, weight loss, tumor location, and treatment, Nutritional status (VGS, Global Subjective Assessment Valoración Global Subjetiva, in Spanish), ECOG performance status; nutritional therapy (oral nutritional supplements, enteral nutrition, parenteral nutrition, dietary advice); type of treatment: chemo, type of chemo, adjuvant, neoadjuvant, palliative, curative endocrine therapy, targeted therapy +-immunotherapy vs QQT/RT therapy; cancer site. Covid-19 diagnosis.

Oncology Patients (Chemo-Radiotherapy group).; Oncology patients (Immunotherapy alone or in combination))

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Total number of subjects to be enrolled: 610 subjects, counting lost. * Number of study or comparison groups: two. * The study will be performed on multiple different days: the recruitment will be concomitant and limited to a minimum of 30 patients depending on the number of patients the center deals with. The estimation is that each center will dedicate from an estimation of twelve weeks to recruit the total number of patients.

You may qualify if:

• 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).
• 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.

You may not qualify if:

• Estimated survival below 12 weeks (palliative criteria).
• Patients that meet diagnostic criteria (DSM-IV and ICD-10) of nervous anorexia and bulimia.
• Patients with severe psychiatric disorders.

Sponsors & Collaborators

• Universidad Pontificia Comillas: lead
• Baxter Healthcare Corporation: collaborator
• Iqvia Pty Ltd: collaborator
• SPANISH SOCIETY OF ONCOLOGY NURSING: collaborator

Study Sites (11)

Hospital Virgen de los Lirios

Alcoy, Alicante, Spain

Location

Hospital Universitario Quirón Madrid

Pozuelo de Alarcón, Madrid, Spain

Location

Clínica Universidad de Navarra

Pamplona, Navarre, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Location

Hospital Universitari Vall d´Hebron

Barcelona, Spain

Location

Universidad Pontificia Comillas

Madrid, 28015, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Spain

Location

Hospital Son Espases

Palma de Mallorca, Spain

Location

Hospital Universitario Donosti

San Sebastián, Spain

Location

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Spain

Location

Hospital Virgen del Rocío

Seville, Spain

Location

Related Publications (9)

• de 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 BACKGROUND

• Arribas 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 BACKGROUND

• Hanahan 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 BACKGROUND

• Escortell 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 BACKGROUND

• Gomez-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 BACKGROUND

• Hebuterne 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 RESULT

• Segura 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.

  PMID: 15993517 RESULT

• Muscaritoli M, Lucia S, Farcomeni A, Lorusso V, Saracino V, Barone C, Plastino F, Gori S, Magarotto R, Carteni G, Chiurazzi B, Pavese I, Marchetti L, Zagonel V, Bergo E, Tonini G, Imperatori M, Iacono C, Maiorana L, Pinto C, Rubino D, Cavanna L, Di Cicilia R, Gamucci T, Quadrini S, Palazzo S, Minardi S, Merlano M, Colucci G, Marchetti P; PreMiO Study Group. Prevalence of malnutrition in patients at first medical oncology visit: the PreMiO study. Oncotarget. 2017 Aug 10;8(45):79884-79896. doi: 10.18632/oncotarget.20168. eCollection 2017 Oct 3.

  PMID: 29108370 RESULT

• Planas M, Alvarez-Hernandez J, Leon-Sanz M, Celaya-Perez S, Araujo K, Garcia de Lorenzo A; PREDyCES(R) researchers. Prevalence of hospital malnutrition in cancer patients: a sub-analysis of the PREDyCES(R) study. Support Care Cancer. 2016 Jan;24(1):429-435. doi: 10.1007/s00520-015-2813-7. Epub 2015 Jun 23.

  PMID: 26099900 RESULT

Related Links

• SEOM, Las cifras del cáncer en España. Cancer database in Spain, year 2019.

MeSH Terms

Conditions

Malnutrition; Neoplasms

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Julio C de la Torre-Montero, Ph.D

  Comillas Pontifical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, professor

Study Record Dates

• First Submitted: November 14, 2019
• First Posted: November 19, 2019
• Study Start: June 10, 2020
• Primary Completion: October 9, 2020
• Study Completion: December 15, 2020
• Last Updated: May 23, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Starting March 2021
• Access Criteria: Open Access

Locations

ES (11)