Lung CancerNCT05417672
Assessment of Relationship Between Preoperative Nutritional Status and Perioperative/Postoperative Conditions in Patients With Lung Cancer Scheduled for Lobectomy
An observational study of Lung Cancer and Malnutrition, run by Turkish Society of Anesthesiology and Reanimation at 1 site in Turkey (Türkiye).
Trial summary
Malnutrition is common in patients with lung cancer. In patients with malnutrition risk, the risk of complications is high both in the perioperative, early and late postoperative periods. Malnutrition is an independent risk factor for length of hospital stay and cost in these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Malnutrition, Nutritional Deficiency
- What is being tested?
- Nutritional Risk Screening-2002, Nutritional Risk Index and Mini Nutritional Assessment
- Type of treatment
- Medical device
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Sep 2021to 1 Sep 2022
- 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: 18 years and older patients who underwent lobectomy with a diagnosis lung cancer
Who may be able to join
- Having a diagnosis of lung cancer
- Lung lobectomy operation will be performed
- 18 years and older patients
- Having an American Society of Anesthesiologists score of 1, 2, 3
- Having approved and signed the informed consent form
Who cannot join
- Patients who underwent lobectomy with a diagnosis other than lung cancer
- Patients younger than 18 years
- Patients with an American Society of Anesthesiologists score of 4 and above
- Patients who did not accept informed consent
- Patients who refused to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bursa Uludağ Üniversitesi Tıp Fakültesi
Bursa, Nilüfer, 16000
Seda Eğilmez, 1, 905063564052, egilmezseda@gmail.com
Nermin Kelebek Girgin, 2, 905323875956, nerminkelebek@yahoo.com
About this study
Malnutrition is common in patients with lung cancer. In patients with malnutrition risk, the risk of complications is high both in the perioperative, early and late postoperative periods. Malnutrition is an independent risk factor for length of hospital stay and cost in these patients. Patients with lung cancer may have many morbidities in postoperative period, especially problems with wound healing. Therefore, assessment of the nutritional status of patients with lung cancer should begin at the diagnosis stage.
Read the detailed description
In patients with lung cancer scheduled for lobectomy, anthropometric measurements will be measured and the results of laboratory tests(albumin, prealbumin, creatinine, total lymphocyte count, C reactive protein), Nutritional Risk Screening-2002, Nutritional Risk Index, Mini Nutritional Assessment, Glasgow Prognostic Score, Prognostic Nutritional Index and neoadjuvant chemotherapy or not will be recorded in 72 hours before surgery. In addition, demographic information of the patients (name, surname, identification number, age, comorbidity, American Society of Anesthesiologists score) will be recorded. After the information is given to the patients, their written and verbal consent will be obtained.
In the operating room, routine monitoring (electrocardiography, invasive blood pressure measurement, arterial blood gas monitoring, peripheral oxygen saturation, end-tidal carbon dioxide measurement by capnography) will be applied to the patients in accordance with the standard protocol for elective lobectomy surgery.
Hemodynamic changes (eg. dysrhythmia, hypotension, hypertension, hemorrhage), metabolic status (pH, bicarbonate, base excess), lactate, glucose level in blood gas evaluation and intraoperative complications will be recorded during the intraoperative period.
In the postoperative period, length of stay in the intensive care unit, length of hospital stay, early complications (eg. dysrhythmia, acute coronary syndrome, sepsis, mediastinitis, pneumonia, surgical site infection, prolonged air leak), time to start oral intake and transition to adequate oral intake will be recorded in the one-month postoperative period.
- Conditions
- Lung Cancer, Malnutrition, Nutritional Deficiency
- Being tested
- Nutritional Risk Screening-2002, Nutritional Risk Index, Mini Nutritional Assessment, Glasgow Prognostic Score, Prognostic Nutritional Index
- Medical subject headings
- Lung Neoplasms, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional Risk Screening-2002Diagnostic test
Nutritional Risk Screening-2002
Nutritional Risk IndexDiagnostic test
Nutritional Risk Index
Mini Nutritional AssessmentDiagnostic test
Mini Nutritional Assessment
Glasgow Prognostic ScoreDiagnostic test
Glasgow Prognostic Score
Prognostic Nutritional IndexDiagnostic test
Prognostic Nutritional Index
Anthropometric measurementsDiagnostic test
middle arm circumference
Handgrip strength testDevice
Handgrip strength test
| Study group | Role | What they receive |
|---|---|---|
| Lung cancer scheduled lobectomy | Not described Receives: Diagnostic Test: Nutritional Risk Screening-2002; Diagnostic Test: Nutritional Risk Index; Diagnostic Test: Mini Nutritional Assessment; Diagnostic Test: Glasgow Prognostic Score; Diagnostic Test: Prognostic Nutritional Index; Diagnostic Test: Anthropometric measurements; Device: Handgrip strength test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
dysrhythmia, acute coronary syndrome, sepsis, mediastinitis, pneumonia, surgical site infection, prolonged air leak
Measured: a month after the surgery
Length of stay in the intensive care unit
Length of stay in the intensive care unit
Measured: up to 30 days
Length of hospital stay
Length of hospital stay
Measured: up to 30 days
Intraoperative hemodynamic complications
dysrhythmia, hypotension, hypertension, hemorrhage
Measured: during the procedure
Secondary outcomes (6)
Oral intake
time to start oral intake and transition to adequate oral intake
Measured: up to 30 days
pH
pH in arterial blood gas evaluation
Measured: during the procedure
bicarbonate
bicarbonate level in arterial blood gas evaluation
Measured: during the procedure
base excess
base excess in arterial blood gas evaluation
Measured: during the procedure
lactate
lactate level in arterial blood gas evaluation
Measured: during the procedure
glucose
glucose level in arterial blood gas evaluation
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start29 Sep 2021
- Primary completion8 Jun 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turkish Society of Anesthesiology and Reanimation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05417672
- Sponsor's protocol ID
- LungCancerMalnutrition
- Status last verified
- Jun 2022
- First submitted
- 2 Jun 2022
- Last updated
- 14 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cederholm T, Barazzoni R, Austin P, Ballmer P, Biolo G, Bischoff SC, Compher C, Correia I, Higashiguchi T, Holst M, Jensen GL, Malone A, Muscaritoli M, Nyulasi I, Pirlich M, Rothenberg E, Schindler K, Schneider SM, de van der Schueren MA, Sieber C, Valentini L, Yu JC, Van Gossum A, Singer P. ESPEN guidelines on definitions and terminology of clinical nutrition. Clin Nutr. 2017 Feb;36(1):49-64. doi: 10.1016/j.clnu.2016.09.004. Epub 2016 Sep 14.
PubMed 27642056McKenna NP, Bews KA, Al-Refaie WB, Colibaseanu DT, Pemberton JH, Cima RR, Habermann EB. Assessing Malnutrition Before Major Oncologic Surgery: One Size Does Not Fit All. J Am Coll Surg. 2020 Apr;230(4):451-460. doi: 10.1016/j.jamcollsurg.2019.12.034. Epub 2020 Feb 26.
PubMed 32113029Detsky AS, McLaughlin JR, Baker JP, Johnston N, Whittaker S, Mendelson RA, Jeejeebhoy KN. What is subjective global assessment of nutritional status? JPEN J Parenter Enteral Nutr. 1987 Jan-Feb;11(1):8-13. doi: 10.1177/014860718701100108.
PubMed 3820522Kondrup J, Rasmussen HH, Hamberg O, Stanga Z; Ad Hoc ESPEN Working Group. Nutritional risk screening (NRS 2002): a new method based on an analysis of controlled clinical trials. Clin Nutr. 2003 Jun;22(3):321-36. doi: 10.1016/s0261-5614(02)00214-5.
PubMed 12765673Vellas B, Guigoz Y, Garry PJ, Nourhashemi F, Bennahum D, Lauque S, Albarede JL. The Mini Nutritional Assessment (MNA) and its use in grading the nutritional state of elderly patients. Nutrition. 1999 Feb;15(2):116-22. doi: 10.1016/s0899-9007(98)00171-3.
PubMed 9990575Neelemaat F, Kruizenga HM, de Vet HC, Seidell JC, Butterman M, van Bokhorst-de van der Schueren MA. Screening malnutrition in hospital outpatients. Can the SNAQ malnutrition screening tool also be applied to this population? Clin Nutr. 2008 Jun;27(3):439-46. doi: 10.1016/j.clnu.2008.02.002. Epub 2008 Apr 18.
PubMed 18395946
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Relationship Between Preoperative Nutritional Status and Perioperative/Postoperative Conditions in Patients With Lung Cancer Scheduled for Lobectomy
- ClinicalTrials.gov ID
- NCT05417672
- Acronym / sponsor ID
- LungCancerMalnutrition
- Conditions
- Lung Cancer, Malnutrition, Nutritional Deficiency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Turkish Society of Anesthesiology and ReanimationUniversity, hospital or other
- Study start
- 29 Sep 2021 (actual)
- Primary completion
- 8 Jun 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 14 Jun 2022 (actual)
- 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.
Malnutrition is common in patients with lung cancer. In patients with malnutrition risk, the risk of complications is high both in the perioperative, early and late postoperative periods. Malnutrition is an independent risk factor for length of hospital stay and cost in these patients. Patients with lung cancer may have many morbidities in postoperative period, especially problems with wound healing. Therefore, assessment of the nutritional status of patients with lung cancer should begin at the diagnosis stage.
Detailed description
In patients with lung cancer scheduled for lobectomy, anthropometric measurements will be measured and the results of laboratory tests(albumin, prealbumin, creatinine, total lymphocyte count, C reactive protein), Nutritional Risk Screening-2002, Nutritional Risk Index, Mini Nutritional Assessment, Glasgow Prognostic Score, Prognostic Nutritional Index and neoadjuvant chemotherapy or not will be recorded in 72 hours before surgery. In addition, demographic information of the patients (name, surname, identification number, age, comorbidity, American Society of Anesthesiologists score) will be recorded. After the information is given to the patients, their written and verbal consent will be obtained.
In the operating room, routine monitoring (electrocardiography, invasive blood pressure measurement, arterial blood gas monitoring, peripheral oxygen saturation, end-tidal carbon dioxide measurement by capnography) will be applied to the patients in accordance with the standard protocol for elective lobectomy surgery.
Hemodynamic changes (eg. dysrhythmia, hypotension, hypertension, hemorrhage), metabolic status (pH, bicarbonate, base excess), lactate, glucose level in blood gas evaluation and intraoperative complications will be recorded during the intraoperative period.
In the postoperative period, length of stay in the intensive care unit, length of hospital stay, early complications (eg. dysrhythmia, acute coronary syndrome, sepsis, mediastinitis, pneumonia, surgical site infection, prolonged air leak), time to start oral intake and transition to adequate oral intake will be recorded in the one-month postoperative period.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung cancer scheduled lobectomy | – | Diagnostic Test: Nutritional Risk Screening-2002, Diagnostic Test: Nutritional Risk Index, Diagnostic Test: Mini Nutritional Assessment, Diagnostic Test: Glasgow Prognostic Score, Diagnostic Test: Prognostic Nutritional Index, Diagnostic Test: Anthropometric measurements, Device: Handgrip strength test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 18 years and older patients who underwent lobectomy with a diagnosis lung cancer
Key inclusion criteria (5 listed)
- Having a diagnosis of lung cancer
- Lung lobectomy operation will be performed
- 18 years and older patients
- Having an American Society of Anesthesiologists score of 1, 2, 3
- Having approved and signed the informed consent form
Key exclusion criteria (5 listed)
- Patients who underwent lobectomy with a diagnosis other than lung cancer
- Patients younger than 18 years
- Patients with an American Society of Anesthesiologists score of 4 and above
- Patients who did not accept informed consent
- Patients who refused to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional Risk Screening-2002Nutritional Risk Screening-2002 | Diagnostic test | Lung cancer scheduled lobectomy |
| Nutritional Risk IndexNutritional Risk Index | Diagnostic test | Lung cancer scheduled lobectomy |
| Mini Nutritional AssessmentMini Nutritional Assessment | Diagnostic test | Lung cancer scheduled lobectomy |
| Glasgow Prognostic ScoreGlasgow Prognostic Score | Diagnostic test | Lung cancer scheduled lobectomy |
| Prognostic Nutritional IndexPrognostic Nutritional Index | Diagnostic test | Lung cancer scheduled lobectomy |
| Anthropometric measurementsmiddle arm circumference | Diagnostic test | Lung cancer scheduled lobectomy |
| Handgrip strength testHandgrip strength test | Device | Lung cancer scheduled lobectomy |
Primary outcome
Postoperative complications
Time frame: a month after the surgery
dysrhythmia, acute coronary syndrome, sepsis, mediastinitis, pneumonia, surgical site infection, prolonged air leak
Length of stay in the intensive care unit
Time frame: up to 30 days
Length of stay in the intensive care unit
Length of hospital stay
Time frame: up to 30 days
Length of hospital stay
Intraoperative hemodynamic complications
Time frame: during the procedure
dysrhythmia, hypotension, hypertension, hemorrhage
6 secondary outcomes
Oral intake
Time frame: up to 30 days
pH
Time frame: during the procedure
bicarbonate
Time frame: during the procedure
base excess
Time frame: during the procedure
lactate
Time frame: during the procedure
glucose
Time frame: during the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
- Background: PubMed 27642056Cederholm T, Barazzoni R, Austin P, Ballmer P, Biolo G, Bischoff SC, Compher C, Correia I, Higashiguchi T, Holst M, Jensen GL, Malone A, Muscaritoli M, Nyulasi I, Pirlich M, Rothenberg E, Schindler K, Schneider SM, de van der Schueren MA, Sieber C, Valentini L, Yu JC, Van Gossum A, Singer P. ESPEN guidelines on definitions and terminology of clinical nutrition. Clin Nutr. 2017 Feb;36(1):49-64. doi: 10.1016/j.clnu.2016.09.004. Epub 2016 Sep 14.
- Background: PubMed 32113029McKenna NP, Bews KA, Al-Refaie WB, Colibaseanu DT, Pemberton JH, Cima RR, Habermann EB. Assessing Malnutrition Before Major Oncologic Surgery: One Size Does Not Fit All. J Am Coll Surg. 2020 Apr;230(4):451-460. doi: 10.1016/j.jamcollsurg.2019.12.034. Epub 2020 Feb 26.
- Background: PubMed 3820522Detsky AS, McLaughlin JR, Baker JP, Johnston N, Whittaker S, Mendelson RA, Jeejeebhoy KN. What is subjective global assessment of nutritional status? JPEN J Parenter Enteral Nutr. 1987 Jan-Feb;11(1):8-13. doi: 10.1177/014860718701100108.
- Background: PubMed 12765673Kondrup J, Rasmussen HH, Hamberg O, Stanga Z; Ad Hoc ESPEN Working Group. Nutritional risk screening (NRS 2002): a new method based on an analysis of controlled clinical trials. Clin Nutr. 2003 Jun;22(3):321-36. doi: 10.1016/s0261-5614(02)00214-5.
- Background: PubMed 9990575Vellas B, Guigoz Y, Garry PJ, Nourhashemi F, Bennahum D, Lauque S, Albarede JL. The Mini Nutritional Assessment (MNA) and its use in grading the nutritional state of elderly patients. Nutrition. 1999 Feb;15(2):116-22. doi: 10.1016/s0899-9007(98)00171-3.
- Background: PubMed 18395946Neelemaat F, Kruizenga HM, de Vet HC, Seidell JC, Butterman M, van Bokhorst-de van der Schueren MA. Screening malnutrition in hospital outpatients. Can the SNAQ malnutrition screening tool also be applied to this population? Clin Nutr. 2008 Jun;27(3):439-46. doi: 10.1016/j.clnu.2008.02.002. Epub 2008 Apr 18.
- Individual participant dataSharing planned: Undecided
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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.
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 Lung Cancer and Malnutrition, run by Turkish Society of Anesthesiology and Reanimation at 1 site in Turkey (Türkiye).
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 14 Jun 2022. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seda Eğilmez (905063564052, egilmezseda@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complications (time frame: a month after the surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05417672, which also lists 6 linked publications.
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 14 Jun 2022.