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

May 16, 2022 updated by: Julio C. de la Torre-Montero, Universidad Pontificia Comillas

An Observational Study of the Nutritional Status in Locally Advanced or Metastatic Solid Cancer Patients While Receiving Immunotherapy in Spain: the NutriOncoSearch (NOS) Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study 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.

Research Question:

What is the current nutritional status in advanced cancer patients receiving immunotherapy or any other targeted therapies in Spain?

Study Background & Rationale:

Malnutrition is a common medical problem in oncology patients. Between 15 and 40% of patients with cancer present weight loss at diagnosis and the incidence of malnutrition increases over the course of the disease until 80% of all cancer 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. These mechanisms include:

  1. Self-sufficiency in growth signals.
  2. Insensitivity to anti-growth signals.
  3. Evading apoptosis.
  4. No breaks in the replicate potential
  5. Sustained angiogenesis. New treatments have been developed thanks to this knowledge including molecular target treatments aimed at these cancer mechanics and to reverse the anti-tumor 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 anti-tumor treatments.

Regarding the nutritional status of cancer patients, some studies have been developed. In France, a 1-day prospective prevalence survey was carried out in 154 public or private hospital wards in 24 French cities. The investigators were to include all patients with cancer who were present at the hospital on the day of the survey and who agreed to participate. The results of this study showed a high prevalence of malnutrition (39%) and a high rate of malnourished patients not receiving nutrition support (42.4%). Recently, the PreMio study (Italy) assessed the nutritional status of cancer patients on their first visit for care. Findings showed that first-visit PreMiO patients were often malnourished or at risk for malnutrition when they entered the study- 40% to 80% of patients had signs and indicators of nutritional impairment- even in early disease stages, particularly in gastroesophageal, pancreatic, head and neck, and colorectal cancer patients.

In Spain, two old studies analyzed the nutritional situation of Spanish oncology patients. The first one is a multicentric study published in 2005 with data from outpatients and hospitalized patients. In this study, the scored PG-SGA indicated that 52% of the patients were moderately or severely malnourished and, of the total population analyzed, 97.6% required some form of nutritional recommendation to prevent, or reverse malnutrition. Since then, only the sub-analysis of the PREDYCES study gave information on the nutritional status of cancer patients (hospitalized) in our country (8). This analysis revealed that 36.4% of hospitalized oncology patients were at nutritional risk at the time of hospital discharge. It also demonstrated its significant association with longer hospital stays and higher healthcare costs. Despite all of this, only 1/3 of patients at nutritional risk received nutritional support. There are little data on the nutritional status of non-hospitalized oncology patients and, to our knowledge, none of them analyzed the effects of new target therapies. As these new therapies represent the future of oncology, it´s of most importance to understand what this effect is. The aim of this observational study is to determine the prevalence of malnutrition (or risk of malnutrition) in the Spanish population of outpatients that receive immunotherapy or any other targeted therapies For that end the investigators would like to explore nutritional status using validated tools like NutriScore, and Global Subjective assessment, Spanish version.

Study Design

Study Type: Clinical Non-Interventional

Condition to be studied and incidence: Nutritional status

Due to the epidemiologic characteristics of this study, the investigators don´t ask about adverse events or their relationship with specific drugs: the investigators will ask for generic groups of agents or treatments.

Study Population (ages, gender, relevant disease states): Adult patients, both sexes, Stages III-IV all solid cancers.

Duration of subject participation: This a descriptive, prospective and analytic study. Patients will be asked once, and no more.

The total number of subjects to be enrolled: 610 subjects.

  • The number of study or comparison groups: two 2:1 relation. 408 patients with immunotherapy with or without chemotherapy or radiotherapy and 204 with chemotherapy or radiotherapy alone, both of them in the first line of treatment,
  • The study will be performed on multiple different days: the recruitment will be concomitant and limited to a minimum of 30 and a maximum of 70 patients depending on the number of patients the center deals with. The estimation is that each center will dedicate from one to two weeks to recruit the total number of patients.

Specific details of Treatment/Intervention: (prescription and/or therapy, devices, equipment, solutions, product to be used in conducting the study:

Not applicable.

Efficacy Assessments Not applicable.

Statistical Methods (for analyzing primary & secondary endpoints):

Descriptive statistics like clinical and sociodemographic characteristics of the studied population will be expressed by means and SDs for the continuous variables and frequency distribution for the qualitative variables. The investigators will use the ӽ2 test and Fisher exact test for the qualitative data set and Student t-test for quantitative data, with a significance level of .05 and a confidence interval of 95%. Multivariate logistic regression analysis and odds ratios can be efficiently conducted as a measure of statistical correlation to link nutrition status and associated factors.

Based on the number of cancer diagnoses in 2019 in Spain (REDECAN), there will be an incidence of 277.234 new cases, with a prevalence of 772.853 cases (5-years projection). With this population the investigators calculate a proportion estimation, with a confidence interval 1-α of 99%, d= 3%, p= 0,5, the sample size is 504, with an expected loss of (R=)15% sample size is 610 subjects. Investigators propose a stratification in two groups, in a 2:1 proportion, 408 patients in the immunotherapy-only group and 204 patients in the control, chemotherapy-in-combination group.

Study Type

Observational

Enrollment (Actual)

586

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain
        • Hospital de La Santa Creu I Sant Pau
      • Barcelona, Spain
        • Hospital Universitari Vall d´Hebron
      • Madrid, Spain
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28015
        • Universidad Pontificia Comillas
      • Palma De Mallorca, Spain
        • Hospital Son Espases
      • San Sebastián, Spain
        • Hospital Universitario Donosti
      • Santa Cruz De Tenerife, Spain
        • Hospital Universitario de Canarias
      • Sevilla, Spain
        • Hospital Virgen Del Rocio
    • Alicante
      • Alcoy, Alicante, Spain
        • Hospital Virgen de los Lirios
    • Madrid
      • Pozuelo De Alarcón, Madrid, Spain
        • Hospital Universitario Quiron Madrid
    • Navarra
      • Pamplona, Navarra, Spain
        • Clinica Universidad de Navarra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Six months
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).
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Pontificia Comillas

Collaborators

Baxter Healthcare Corporation
Iqvia Pty Ltd
SPANISH SOCIETY OF ONCOLOGY NURSING

Investigators

  • Principal Investigator: Julio C de la Torre-Montero, Ph.D, Comillas Pontifical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2020

Primary Completion (Actual)

October 9, 2020

Study Completion (Actual)

December 15, 2020

Study Registration Dates

First Submitted

November 14, 2019

First Submitted That Met QC Criteria

November 18, 2019

First Posted (Actual)

November 19, 2019

Study Record Updates

Last Update Posted (Actual)

May 23, 2022

Last Update Submitted That Met QC Criteria

May 16, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SEEO-19-01-NOS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Dissemination in biomedical research journals

IPD Sharing Time Frame

Starting March 2021

IPD Sharing Access Criteria

Open Access

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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