Ignite Creation Date:
2024-05-06 @ 8:26 AM
Last Modification Date:
2024-10-26 @ 12:00 PM
Study NCT ID:
NCT02734069
Status:
RECRUITING
Last Update Posted:
2024-01-24
First Post:
2016-03-31
Brief Title:
Impact of Fat-free Mass in the Carboplatin Calculated Dose and Chemotherapeutic Toxicity in Patients With Advanced NSCLC
Sponsor:
Instituto Nacional de Cancerologia de Mexico
Organization:
Instituto Nacional de Cancerologia de Mexico
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 CarboplatinPaclitaxel 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 194 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
Lung cancer LC is the leading cause of cancer deaths worldwide are attributed about 13 of all new cases of cancer and accounts for 194 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None