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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.


N/A
18 Years
N/A
Not Enrolling
Both
Weight Loss, Cachexia

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Trial Information

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.


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

30months

Safety Issue:

No

Authority:

Norway: The Regional Comittees for Medical and Health Research Ethics in Norway

Study ID:

2012/830/REK sør-øst D

NCT ID:

NCT01865903

Start Date:

June 2013

Completion Date:

December 2017

Related Keywords:

  • Weight Loss
  • Cachexia
  • NSCLC
  • sarcopenia
  • cachexia
  • Cachexia
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Nutrition Disorders
  • Weight Loss

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