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

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ClinicalTrials.gov Identifier: NCT04168814
Recruitment Status : Completed
First Posted : November 19, 2019
Last Update Posted : January 22, 2021
Sponsor:
Collaborators:
Baxter Healthcare Corporation
Iqvia Pty Ltd
SPANISH SOCIETY OF ONCOLOGY NURSING
Information provided by (Responsible Party):
JULIO CESAR DE LA TORRE MONTERO, Universidad Pontificia Comillas

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.


Condition or disease Intervention/treatment
Malnutrition Oncologic Complications Oncology Quality of Life Other: Observational test

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Study Type : Observational
Actual Enrollment : 586 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: An Observational Study of the Nutritional Status in Locally Advanced or Metastatic Solid Cancer Patients While Receiving Immunotherapy in Spain: the NutriOncoSearch (NOS) Study
Actual Study Start Date : June 10, 2020
Actual Primary Completion Date : October 9, 2020
Actual Study Completion Date : December 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

Group/Cohort Intervention/treatment
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
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).
  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
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.




Primary Outcome Measures :
  1. Nutritional status [ Time Frame: Six months ]
    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.


Secondary Outcome Measures :
  1. Nutritional counselling [ Time Frame: Six months ]
    To describe the percentage of patients that receive nutritional counselling or nutritional support (enteral and/or parenteral nutrition) among those diagnosed as malnourished or at risk.

  2. Descriptive characteristic mild, moderate or severe malnutrition [ Time Frame: Six months ]
    To categorize the percentage and descriptive characteristic of cancer patients with mild, moderate or severe malnutrition that goes to a hospital consultation in Spain and describe the percentage and descriptive characteristic of patients with malnutrition according to sociodemographic and clinical characteristics (type of tumor and TNM stage).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04168814


Locations
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Spain
Hospital Virgen de los Lirios
Alcoy, Alicante, Spain
Hospital Universitario Quirón Madrid
Pozuelo De Alarcón, Madrid, Spain
Clínica Universidad de Navarra
Pamplona, Navarra, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Universitari Vall d´Hebron
Barcelona, Spain
Universidad Pontificia Comillas
Madrid, Spain, 28015
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Son Espases
Palma De Mallorca, Spain
Hospital Universitario Donosti
San Sebastián, Spain
Hospital Universitario de Canarias
Santa Cruz De Tenerife, Spain
Hospital Virgen del Rocío
Sevilla, Spain
Sponsors and Collaborators
Universidad Pontificia Comillas
Baxter Healthcare Corporation
Iqvia Pty Ltd
SPANISH SOCIETY OF ONCOLOGY NURSING
Investigators
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Principal Investigator: Julio C de la Torre-Montero, Ph.D Comillas Pontifical University
Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: JULIO CESAR DE LA TORRE MONTERO, Principal Investigator, professor, Universidad Pontificia Comillas
ClinicalTrials.gov Identifier: NCT04168814    
Other Study ID Numbers: SEEO-19-01-NOS
First Posted: November 19, 2019    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Dissemination in biomedical research journals
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Starting March 2021
Access Criteria: Open Access

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by JULIO CESAR DE LA TORRE MONTERO, Universidad Pontificia Comillas:
Nutritional status
Oncology Patients
Anticancer treatments
Quality of Life
Additional relevant MeSH terms:
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Neoplasms
Malnutrition
Nutrition Disorders