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

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ClinicalTrials.gov Identifier: NCT01865903
Recruitment Status : Terminated (To Low recruitment and competing studies)
First Posted : May 31, 2013
Last Update Posted : July 14, 2015
Sponsor:
Collaborators:
Diakonhjemmet Hospital
Lovisenberg Diakonale Hospital
Information provided by (Responsible Party):
Oslo University Hospital

Tracking Information
First Submitted Date May 8, 2013
First Posted Date May 31, 2013
Last Update Posted Date July 14, 2015
Study Start Date June 2013
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 28, 2013)
Nutritional Problems and Changes in Body Composition in Patients With Non-small Cell Lung Cancer (LEKS) [ Time Frame: 30months ]
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01865903 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 28, 2013)
The relation between nutrition, tumor burden and outcome [ Time Frame: 30 months ]
1. The interaction between negative energy balance and inflammation-driven catabolism, and tumor burden and analyse the predictive impact on QoL and survival
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Nutritional Problems and Changes in Body Composition in Patients With Non-small Cell Lung Cancer (LEKS)
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.
Brief Summary 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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Bloodsamples for biobank
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.
Condition
  • Weight Loss
  • Cachexia
Intervention Not Provided
Study 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: July 13, 2015)
17
Original Estimated Enrollment
 (submitted: May 28, 2013)
200
Estimated Study Completion Date December 2017
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Norway
Removed Location Countries  
 
Administrative Information
NCT Number NCT01865903
Other Study ID Numbers 2012/830/REK sør-øst D
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Oslo University Hospital
Study Sponsor Oslo University Hospital
Collaborators
  • Diakonhjemmet Hospital
  • Lovisenberg Diakonale Hospital
Investigators Not Provided
PRS Account Oslo University Hospital
Verification Date May 2013