Weight LossLEKSNCT01865903
Nutritional Problems and Changes in Body Composition in Patients With Non-small Cell Lung Cancer (LEKS)
An observational study of Weight Loss and Cachexia, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weight Loss, Cachexia
- How many people
- 17 participants
- Where
- 1 siteNorway
- Study dates
- 15 Jun 2013to 4 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Clinical diagnosis of NSCLC.
- No other active cancer.
- Must be able to consent.
- Fluent in Norwegian.
Who cannot join
- Other active cancer than NSCLC
- Younger than 18 years
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Weight Loss, Cachexia
- Keywords
- NSCLC, sarcopenia, cachexia
- Medical subject headings
- Weight Loss, Cachexia, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional Problems and Changes in Body Composition in Patients With Non-small Cell Lung Cancer (LEKS)
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.
Measured: 30months
Secondary outcomes (1)
The relation between nutrition, tumor burden and outcome
- The interaction between negative energy balance and inflammation-driven catabolism, and tumor burden and analyse the predictive impact on QoL and survival
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2013 (estimated)
- Study start15 Jun 2013
- Primary completion4 Feb 2020
- Study completion4 Feb 2020
Why it stopped: To Low recruitment and competing studies
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Diakonhjemmet Hospital, Lovisenberg Diakonale Hospital
- Responsible party
- Principal investigator, Kjersti Hornslien, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01865903
- Sponsor's protocol ID
- 2012/830/REK sør-øst D
- Acronym
- LEKS
- Status last verified
- Mar 2020
- First submitted
- 8 May 2013
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01865903
- Acronym / sponsor ID
- LEKS / 2012/830/REK sør-øst D
- Conditions
- Weight Loss, Cachexia
- Keywords
- NSCLC, sarcopenia, cachexia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: To Low recruitment and competing studies
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Diakonhjemmet Hospital, Lovisenberg Diakonale Hospital
- Study start
- 15 Jun 2013 (actual)
- Primary completion
- 4 Feb 2020 (actual)
- Study completion
- 4 Feb 2020 (actual)
- First posted
- 31 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Clinical diagnosis of NSCLC.
- No other active cancer.
- Must be able to consent.
- Fluent in Norwegian.
Key exclusion criteria (2 listed)
- Other active cancer than NSCLC
- Younger than 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
The relation between nutrition, tumor burden and outcome
Time frame: 30 months
Results and safety
The study was stopped early (reason given: To Low recruitment and competing studies). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Weight Loss and Cachexia, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: To Low recruitment and competing studies). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutritional Problems and Changes in Body Composition in Patients With Non-small Cell Lung Cancer (LEKS) (time frame: 30months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2020.