Prognostic Value of Body Composition in Lung Cancer

August 21, 2022 updated by: Marmara University

Prognostic Value of Body Composition in Therapy-Naïve Patients With Non-Small Cell Lung Cancer

The effect of body composition on the survival rate is one of the research topics of interest in cancer patients and gaining attention in the last years. Body mass index is often used a proxy measure of total adiposity and previous studies examining the relationship between BMI and cancer outcomes have been showed distinct results . Obese patients with malignancies such as colorectal, breast, and pancreatic cancers, have been shown to have a worse prognosis than normal-weight patients . Nevertheless, obese patients with non small cell lung cancer(NSCLC) have been observed to have a better clinical outcome than normal/low-weight cancer patients . In this study, we examined the effects of subcutaneous adipose tissue, visceral adipose tissue and skeletal muscle volumes on survival in metastatic NSCLC patients under different treatment regimens. Since there is no standard method for adipose tissue measurement, we evaluated the abdominal cavity with multi-slice and single-slice computed tomography measurements.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

83

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İstanbul, Turkey, 34870
        • Tuğba Kıratlı Yolcu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Eighty-three patients with stage-IV NSCLC who received at least one cycle of platinum based chemotherapy (PBCT) or tyrosine kinase inhibitor (TKI) therapy and who underwent pre treatment FDG PET/CT from June 2012 to February 2019

Description

Inclusion Criteria:

  1. Having a pathological diagnosis of non small cell lung cancer
  2. Having a stage-IV disease
  3. To have received at least one course of treatment
  4. Presence of positron emission tomography /computed tomography (PET/CT) examination before treatment and having it taken in our hospital
  5. The data about the study can be accessed in our center.
  6. To be over 18 years old

Exclusion Criteria:

  1. Unable to access patients data
  2. PET/CT CDs cannot be accessed or are not suitable for evaluation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Stage-IV non small cell lung cancer (NSCLC)
Eighty-three patients with stage-IV NSCLC who received at least one cycle of platinum based chemotherapy (PBCT) or tyrosine kinase inhibitor (TKI) therapy and who underwent pre treatment fluorodeoxyglucose (FDG)-positron emission tomography (PET) /computed tomography (FDG PET/CT) from June 2012 to February 2019
Other: measured of body composition with computed tomography
Multislice and single-slice computed tomography images were used for assessment of body composition including visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT), skeletal muscle mass volume (SMMV)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the impact of visceral adipose tissue (VAT) on the prognosis of metastatic non-small cell lung cancer (NSCLC) patients.
Time Frame: through study completion, an average of 6 months
Visceral adipose tissue (VAT) area was measured by using computed tomography (CT). The entire abdominopelvic region from the "diaphragm dome" to the "symphysis pubis" level was determined as the study area. The volume was recorded as cm3. Index values were calculated by proportioning VAT to body surface area (BSA) and median index value was determined. The survival rates of patients with an index value greater and less than the mean index value were compared.
through study completion, an average of 6 months
To evaluate the impact of subcutaneous adipose tissue (SAT) on the prognosis of metastatic non-small cell lung cancer (NSCLC) patients.
Time Frame: through study completion, an average of 6 months
Subcutaneous adipose tissue (SAT) area was measured by using computed tomography (CT). The entire abdominopelvic region from the "diaphragm dome" to the "symphysis pubis" level was determined as the study area. The volume was recorded as cm3. Index values were calculated by proportioning SAT to body surface area (BSA) and median index value was determined. The survival rates of patients with an index value greater and less than the mean index value were compared.
through study completion, an average of 6 months
To evaluate the impact of skeletal muscle mass volume (SMMV) on the prognosis of metastatic non-small cell lung cancer (NSCLC) patients.
Time Frame: through study completion, an average of 6 months
Skeletal muscle mass volume (SMMV) area was measured by using computed tomography (CT). For SMMV calculation, paraspinal muscle tissue located between L2-L5 lumbar vertebrae levels was determined . The volume was recorded as cm3. Index values were calculated by proportioning SMMV to body surface area (BSA) and median index value was determined. The survival rates of patients with an index value greater and less than the mean index value were compared.
through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

June 1, 2019

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

August 18, 2022

First Submitted That Met QC Criteria

August 21, 2022

First Posted (Actual)

August 23, 2022

Study Record Updates

Last Update Posted (Actual)

August 23, 2022

Last Update Submitted That Met QC Criteria

August 21, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09.2019.1026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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