Nutritional Problems and Changes in Body Composition in Patients With Non-small Cell Lung Cancer (LEKS)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2013 by Oslo University Hospital
Sponsor:
Collaborators:
Diakonhjemmet Hospital
Lovisenberg Diakonale Hospital
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01865903
First received: May 8, 2013
Last updated: May 28, 2013
Last verified: May 2013
  Purpose

Weight loss and loss of lean body mass are common and associated with adverse outcomes such as loss of strength, reduced immune- and pulmonary function and increased disability in advanced cancer. Progressive weight loss interferes with cancer therapy and is responsible for reduced quality of life (QoL) as well as shorter survival irrespective of tumour mass or presence of metastases. Weight loss in advanced cancer is regarded as a major clinical challenge because of its serious consequences, its varying aetiology and the contribution of multiple pathophysiological mechanisms that are poorly disentangled.


Condition
Weight Loss
Cachexia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Nutritional Problems and Changes in Body Composition in Patients With Non-small Cell Lung Cancer; Incidence, Development and Impact on Quality of Life, Adverse Effects and Survival.

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Nutritional Problems and Changes in Body Composition in Patients With Non-small Cell Lung Cancer (LEKS) [ Time Frame: 30months ] [ Designated as safety issue: No ]
    To describe the status of nutrition and body composition in all patients with non small cell lung cancer at the moment of diagnose in a certain period of time, and to follow the possible changes in the same in those patients who then afterwards receive palliative chemotherapy.


Secondary Outcome Measures:
  • The relation between nutrition, tumor burden and outcome [ Time Frame: 30 months ] [ Designated as safety issue: No ]
    1. The interaction between negative energy balance and inflammation-driven catabolism, and tumor burden and analyse the predictive impact on QoL and survival


Biospecimen Retention:   Samples With DNA

Bloodsamples for biobank


Estimated Enrollment: 200
Study Start Date: June 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cohort 1
All with diagnose of NSCLC in Oslo during 6 months
Cohort 2
All NSCLC in Ulleval university hospital whom are in need of palliative chemotherapy

Detailed Description:

Weight loss and loss of lean body mass are common and associated with adverse outcomes such as loss of strength, reduced immune- and pulmonary function and increased disability in advanced cancer. Progressive weight loss interferes with cancer therapy and is responsible for reduced quality of life (QoL) as well as shorter survival irrespective of tumour mass or presence of metastases. Weight loss in advanced cancer is regarded as a major clinical challenge because of its serious consequences, its varying aetiology and the contribution of multiple pathophysiological mechanisms that are poorly disentangled.

The main contributor to weight loss in advanced cancer is considered to be development of cancer cachexia. The term refers to a syndrome of progressive loss of body weight and muscle atrophy involving two parallel pathways, i.e. negative energy balance and inflammation-driven catabolism. The negative energy balance may be a direct result of malnutrition caused by cancer and treatment related symptoms that interfere with food intake and routine assessment of nutritional status is therefore advocated. The interaction and relative contribution of these pathways in the development of cancer cachexia are, however, poorly understood. Through novel use of traditional clinical data and biological markers, we propose to investigate the interplay and magnitude of the processes involved in the development of cancer cachexia. This will contribute to a new understanding that may lead to more precise identification of remediable factors and improved treatment. In this context, we will also investigate the relevance of using screening tools for nutritional status, as advocated by the Norwegian Health Authorities. However, in advanced cancer the identifying ability of the recommended screening tools is poorly documented.

The present study is part of a larger project by our group. The overall project includes two parallel studies based on the same comprehensive data collection, targeting patients with non-small cell lung cancer (NSCLC). Tumours of the lung are one of the most common causes of cancer related weight loss. These patients are therefore an ideal target for studying the mechanisms and impact of nutritional problems and cachexia, as proposed in the present study. The other parallel study, which is approved by the Regional Committee for Medical and Health Research Ethics (REC), Region South East (2012/830), aims at describing the frequency and development of weight loss in NSCLC patients, and its relation to tumour stage, response and side effects of chemotherapy.

This study also makes part of a larger research effort focusing on cachexia and changes in body composition in cancer patients by our group. A study on the impact of sarcopenia (severe muscle loss) in NSCLC is ongoing as well a prospective study on cachexia in pancreatic cancer, using the same assessments as the present study. The present study will significantly contribute to the understanding of the mechanisms of weight loss and cachexia in advanced cancer in general and in NSCLC in particular, and will provide knowledge that is needed to improve medical treatment and follow-up of a large group of patients. Thus, the study is in line with the research strategy from the South-Eastern Norway Regional Health Authority (South-Eastern Norway RHA). Furthermore, the study emerges from a multidisciplinary research network representing several areas of medical and nutritional expertise and with an established international partnership.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

About 250 new cases of lung cancer are diagnosed in Oslo every year. About 200 of these belong to the defined catchment area for the present study. Approximately 150 patients are expected to be in a palliative setting. Based on the number of new referrals to OUS Ullevål in 2011, about 60-80 patients with NSCLC will be starting first line palliative chemotherapy every year. A sample size of 110 patients is planned for this study Cohort 2, which gives an enrolment period of about 2 years In Cohort 1 another 50 patients.

Criteria

Inclusion Criteria:

  • Clinical diagnosis of NSCLC.
  • No other active cancer.
  • Must be able to consent.
  • Fluent in Norwegian.

Exclusion Criteria:

  • Other active cancer than NSCLC
  • Younger than 18 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01865903

Contacts
Contact: Marit S. Jordhøy, MD PhD 23026600 ext +47 mjordhoy@online.no
Contact: Kjersti Hornslien, MD 23026600 ext +47 kjersti.hornslien@ous-hf.no

Locations
Norway
Oslo University Hospital Not yet recruiting
Oslo, Norway, N-0450
Contact: Marit S Jordhøy, MD PhD    23026600 ext +47    mjordhoy@online.no   
Contact: Kjersti Hornslien, MD    23026600 ext +47    kjersti.hornslien@ous-hf.no   
Principal Investigator: Marit S. Jordhoy, MD PhD         
Sponsors and Collaborators
Oslo University Hospital
Diakonhjemmet Hospital
Lovisenberg Diakonale Hospital
  More Information

No publications provided

Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01865903     History of Changes
Other Study ID Numbers: 2012/830/REK sør-øst D
Study First Received: May 8, 2013
Last Updated: May 28, 2013
Health Authority: Norway: The Regional Comittees for Medical and Health Research Ethics in Norway

Keywords provided by Oslo University Hospital:
NSCLC
sarcopenia
cachexia

Additional relevant MeSH terms:
Nutrition Disorders
Malnutrition
Cachexia
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Weight Loss
Emaciation
Body Weight Changes
Body Weight
Signs and Symptoms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 28, 2014