NCT05417672

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
63

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 29, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2022

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 14, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

June 14, 2022

Status Verified

June 1, 2022

Enrollment Period

8 months

First QC Date

June 2, 2022

Last Update Submit

June 9, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • Postoperative complications

    dysrhythmia, acute coronary syndrome, sepsis, mediastinitis, pneumonia, surgical site infection, prolonged air leak

    a month after the surgery

  • Length of stay in the intensive care unit

    Length of stay in the intensive care unit

    up to 30 days

  • Length of hospital stay

    Length of hospital stay

    up to 30 days

  • Intraoperative hemodynamic complications

    dysrhythmia, hypotension, hypertension, hemorrhage

    during the procedure

Secondary Outcomes (6)

  • Oral intake

    up to 30 days

  • pH

    during the procedure

  • bicarbonate

    during the procedure

  • base excess

    during the procedure

  • lactate

    during the procedure

  • +1 more secondary outcomes

Study Arms (1)

Lung cancer scheduled lobectomy

Diagnostic Test: Nutritional Risk Screening-2002Diagnostic Test: Nutritional Risk IndexDiagnostic Test: Mini Nutritional AssessmentDiagnostic Test: Glasgow Prognostic ScoreDiagnostic Test: Prognostic Nutritional IndexDiagnostic Test: Anthropometric measurementsDevice: Handgrip strength test

Interventions

Nutritional Risk Screening-2002

Lung cancer scheduled lobectomy
Nutritional Risk IndexDIAGNOSTIC_TEST

Nutritional Risk Index

Lung cancer scheduled lobectomy

Mini Nutritional Assessment

Lung cancer scheduled lobectomy

Glasgow Prognostic Score

Lung cancer scheduled lobectomy

Prognostic Nutritional Index

Lung cancer scheduled lobectomy

middle arm circumference

Lung cancer scheduled lobectomy

Handgrip strength test

Lung cancer scheduled lobectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

18 years and older patients who underwent lobectomy with a diagnosis lung cancer

You may qualify if:

  • Having a diagnosis of lung cancer
  • Lung lobectomy operation will be performed
  • years and older patients
  • Having an American Society of Anesthesiologists score of 1, 2, 3
  • Having approved and signed the informed consent form

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa Uludağ Üniversitesi Tıp Fakültesi

Bursa, Nilüfer, 16000, Turkey (Türkiye)

RECRUITING

Related Publications (6)

  • 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.

    PMID: 27642056BACKGROUND
  • McKenna 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.

    PMID: 32113029BACKGROUND
  • Detsky 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.

    PMID: 3820522BACKGROUND
  • Kondrup 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.

    PMID: 12765673BACKGROUND
  • Vellas 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.

    PMID: 9990575BACKGROUND
  • Neelemaat 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.

    PMID: 18395946BACKGROUND

MeSH Terms

Conditions

Lung NeoplasmsMalnutrition

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesNutrition DisordersNutritional and Metabolic Diseases

Central Study Contacts

Nermin Kelebek Girgin

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2022

First Posted

June 14, 2022

Study Start

September 29, 2021

Primary Completion

June 8, 2022

Study Completion

September 1, 2022

Last Updated

June 14, 2022

Record last verified: 2022-06

Locations