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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02734069
Enrollment
132
Registered
2016-04-12
Start date
2016-02-29
Completion date
2027-12-31
Last updated
2025-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer, Sarcopenia, Toxicity

Keywords

carboplatin

Brief summary

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.

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.

Interventions

DRUGCarboplatin

Patients will receive carboplatin according to the carboplatin area under the curve dose calculation for 2 cycles to evaluate toxicity.

Sponsors

Instituto Nacional de Cancerologia de Mexico
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0Three weeks after the application of chemotherapy to detect changes from BaselineDetermine if the dose of carboplatin-based chemotherapy in patients according to the amount of fat-free mass is directly associated with toxicity

Secondary

MeasureTime frameDescription
Compare different formulas to calculate Glomerular Filtration Rate taking as gold standard cystatin cBasal evaluationCalculate 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).

Countries

Mexico

Contacts

Primary ContactOscar Arrieta, MD, M Sc
ogar@unam.mx015556280400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026