Clinical trial NCT02734069: Impact of Fat-free Mass in the Carboplatin Calculated Dose and Chemotherapeutic Toxicity in Patients With Advanced NSCLC
Official title: Impact of Fat-free Mass in the Carboplatin Calculated Dose and Chemotherapeutic Toxicity in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Sarcopenia
Toxicity
Keywords: carboplatin
Lead sponsor: Instituto Nacional de Cancerologia de Mexico
Sponsor class: OTHER
First posted: 2016-04-12
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: Three weeks after the application of chemotherapy to detect changes from Baseline
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: Six weeks after the application of chemotherapy to detect changes from Baseline
Secondary outcomes:
measure: Compare different formulas to calculate Glomerular Filtration Rate taking as gold standard cystatin c
timeFrame: Basal evaluation
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Cancerologia
Study officials:
affiliation: Instituto Nacional de Cancerologia, Columbia
name: Oscar Arrieta, MD, MSc
role: PRINCIPAL_INVESTIGATOR
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