Impact of Fat-free Mass in the Carboplatin Calculated Dose and Chemotherapeutic Toxicity in Patients With Advanced NSCLC

December 17, 2025 updated by: Oscar Gerardo Arrieta Rodríguez, Instituto Nacional de Cancerologia de Mexico

Impact of Fat-free Mass in the Carboplatin Calculated Dose and Chemotherapeutic Toxicity in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

This study evaluate the association of body composition (mainly free-fat mass), clinical and biochemical parameters with development of toxicity in patients under treatment with Carboplatin/Paclitaxel in advanced NSCLC.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

BACKGROUND

Lung cancer (LC) is the leading cause of cancer deaths worldwide, are attributed about 13% of all new cases of cancer and accounts for 19.4% of deaths from malignancies. In Mexico, this cancer is also the leading cause of death in malignant neoplasias. One of the reasons attributable the high mortality from this disease is that most cases are detected in advanced stages and this depends prognosis and treatment. Within the classification of LC the most prevalent is the Non Small Cell Lung Cancer (NSCLC); for which the considered first-line standard treatment is palliative cytotoxic chemotherapy, as the combination of carboplatin with paclitaxel and in the other hand one of the most recent combinations Carboplatin with Pemetrexed.

Malnutrition may affect 80% of patients with advanced cancer and is associated with up to 20% of deaths, with an increased risk in the development of complications and mortality and can extend the hospital stay up to 90%, increasing the cost of treatment in a 35-75%. Similarly, in a previous study at INCan, the degree of malnutrition in patients with LC was associated with cytotoxic chemotherapy toxicity and poorer prognosis and poorer quality of life. Sarcopenia is also a phenomenon commonly observed in patients with LC, there has been a prevalence of 61% and 31% in men and women respectively.

Carboplatin dose that is administered to the patient is calculated by the Calvert formula, this requires the calculation of glomerular filtration rate (GFR). There are various quantified and estimated methods to calculate GFR; however the validated and most commonly used is estimated by the Cockroft-Gault formulae. It is known that due to various factors, variables required for calculation (as creatinine) could be modify the result, may became unreliable, it is why it is important to consider changes in body composition of NSCLC patients with sarcopenia.

HYPOTHESIS:

Sarcopenia participants receive a 20% more dose of Carboplatin per Free Fat Mass (kg / mg) than those without sarcopenia.

Sarcopenic patients, have more severe toxicity related to chemotherapy than those without sarcopenia.

METHODOLOGY:

NSCLC patients with advanced NSCLC (inoperable stage III or IV ) will be included.

Clinicopathological baseline of patients such as age, sex, stage, ECOG, weight, height, body composition, Subjective Global Assessment, frequency of food consumption, albumin, hemoglobin, hematocrit, glomerular filtration rate, carboplatin administered dosage, quality of life, etc.

A subsequent follow-up evaluation will be made after 1st and 2nd cycle of treatment to assess toxicity.

Study Type

Observational

Enrollment (Estimated)

132

Contacts and Locations

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

Study Contact

  • Name: Oscar Arrieta, MD, M Sc
  • Phone Number: 44001 015556280400
  • Email: ogar@unam.mx

Study Locations

  • Mexico
      • Mexico City, Mexico, 14080
        • Recruiting
        • Instituto Nacional de Cancerologia
        • Contact:
          • Oscar Arrieta
          • Phone Number: 015556280400

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with advanced NSCLC, as candidates for the first line chemotherapy regimen of carboplatin / paclitaxel or Carboplatin / Pemetrexed

Description

Inclusion Criteria:

  • Diagnosis of NSCLC Stage IV (stratification according to the American Joint Committee on Cancers - 7th edition)
  • Candidates for treatment with carboplatin plus paclitaxel 1st line
  • Performance status (ECOG 0-2)
  • Laboratory studies that demonstrate adequate renal, hepatic and hematologic function (blood chemistry and blood count)
  • Normal renal ultrasound prior to initiation of treatment

Exclusion Criteria:

  • Patients with renal impairment (KDOQI 3-5)
  • Patients who do not have computed tomography study at baseline
  • Uncontrolled blood pressure (> 140 mmHg)
  • Uncontrolled diabetes (> 130 mg / dL)
  • Obstruction in kidney (s) or ureter (s)
  • Dehydrated patients
  • Patients with high consumption of NSAIDs (aspirin, ibuprofen, etc.> 1 month)

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Sarcopenic
Patients with sarcopenia (evaluated according to CT scans) will be followed up through treatment with carboplatin for identification of any toxicity grade 3 or 4 (Common Terminology Criteria of Adverse Events)
Drug: Carboplatin
Patients will receive carboplatin according to the carboplatin area under the curve dose calculation for 2 cycles to evaluate toxicity.
Other Names:
  • CARBOPLAT
Non Sarcopenic
Patients without sarcopenia (evaluated according to CT scans) will be followed up through treatment with carboplatin for identification of any toxicity grade 3 or 4 (Common Terminology Criteria of Adverse Events)
Drug: Carboplatin
Patients will receive carboplatin according to the carboplatin area under the curve dose calculation for 2 cycles to evaluate toxicity.
Other Names:
  • CARBOPLAT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: Three weeks after the application of chemotherapy to detect changes from Baseline
Determine if the dose of carboplatin-based chemotherapy in patients according to the amount of fat-free mass is directly associated with toxicity
Three weeks after the application of chemotherapy to detect changes from Baseline
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: Six weeks after the application of chemotherapy to detect changes from Baseline
Determine if the dose of carboplatin-based chemotherapy in patients according to the amount of fat-free mass is directly associated with toxicity
Six weeks after the application of chemotherapy to detect changes from Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare different formulas to calculate Glomerular Filtration Rate taking as gold standard cystatin c
Time Frame: Basal evaluation
Calculate the glomerular filtration rate given the amount of fat-free mass (MSA-eCrCl) and correlate with cystatin C and formulas as Cockroft-Gault, Levey, The Modification of Diet in Renal Disease (MDRD) and Chronic kidney disease epidemiology collaboration (CKD-EPI).
Basal evaluation

Collaborators and Investigators

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

Sponsor

Instituto Nacional de Cancerologia de Mexico

Investigators

  • Principal Investigator: Oscar Arrieta, MD, MSc, Instituto Nacional de Cancerologia, Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 1, 2016

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

March 31, 2016

First Submitted That Met QC Criteria

April 5, 2016

First Posted (Estimated)

April 12, 2016

Study Record Updates

Last Update Posted (Estimated)

December 24, 2025

Last Update Submitted That Met QC Criteria

December 17, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCAN/TOX/CBP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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.

Clinical Trials on Lung Cancer

Clinical Trials on Carboplatin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Argentina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe