Prognostic Value of Body Composition in Lung Cancer

• Sponsor: Marmara University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05512429
• Collaborator: (none)
• Enrollment: 83
• Location: 1
• Actual Duration (Months): 5.9
• Patients Per Site Per Month: 14

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Body Composition and Non-small Cell Lung Cancer	Other: measured of body composition with computed tomography

Study Design

• Study Type: Observational
• Actual Enrollment: 83 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Prognostic Value of Body Composition in Therapy-Naïve Patients With Non-Small Cell Lung Cancer
• Actual Study Start Date: Jan 1, 2019
• Actual Primary Completion Date: Jun 1, 2019
• Actual Study Completion Date: Jul 1, 2019

Arms and Interventions

Arm	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)

Outcome Measures

Primary Outcome Measures

1. To evaluate the impact of visceral adipose tissue (VAT) on the prognosis of metastatic non-small cell lung cancer (NSCLC) patients. [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.

2. To evaluate the impact of subcutaneous adipose tissue (SAT) on the prognosis of metastatic non-small cell lung cancer (NSCLC) patients. [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.

3. To evaluate the impact of skeletal muscle mass volume (SMMV) on the prognosis of metastatic non-small cell lung cancer (NSCLC) patients. [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tuğba Kıratlı Yolcu	İstanbul		Turkey	34870

Sponsors and Collaborators

• Marmara University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Marmara University
• ClinicalTrials.gov Identifier: NCT05512429
• Other Study ID Numbers: 09.2019.1026
• First Posted: Aug 23, 2022
• Last Update Posted: Aug 23, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Aug 23, 2022