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

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ClinicalTrials.gov Identifier: NCT02734069
Recruitment Status : Unknown
Verified April 2016 by Oscar Gerardo Arrieta Rodríguez MD, Instituto Nacional de Cancerologia de Mexico.
Recruitment status was:  Recruiting
First Posted : April 12, 2016
Last Update Posted : April 13, 2016
Sponsor:
Information provided by (Responsible Party):
Oscar Gerardo Arrieta Rodríguez MD, Instituto Nacional de Cancerologia de Mexico

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.

Condition or disease Intervention/treatment
Lung Cancer Sarcopenia Toxicity Drug: Carboplatin

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.


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Study Type : Observational
Estimated Enrollment : 132 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : February 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Carboplatin

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 Name: 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 Name: CARBOPLAT




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02734069


Contacts
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Contact: Oscar Arrieta, MD, M Sc 015556280400 ext 71101 ogar@unam.mx

Locations
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Mexico
Instituto Nacional de Cancerologia Recruiting
Mexico City, Mexico, 14080
Contact: Oscar Arrieta    015556280400      
Sponsors and Collaborators
Instituto Nacional de Cancerologia de Mexico
Investigators
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Principal Investigator: Oscar Arrieta, MD, MSc Instituto Nacional de Cancerologia, Columbia

Publications:

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Responsible Party: Oscar Gerardo Arrieta Rodríguez MD, Head of the Thoracic Oncology Unit and Laboratory of Experimental Oncology, Instituto Nacional de Cancerologia de Mexico
ClinicalTrials.gov Identifier: NCT02734069     History of Changes
Other Study ID Numbers: INCAN/TOX/CBP
First Posted: April 12, 2016    Key Record Dates
Last Update Posted: April 13, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Oscar Gerardo Arrieta Rodríguez MD, Instituto Nacional de Cancerologia de Mexico:
carboplatin
Additional relevant MeSH terms:
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Lung Neoplasms
Sarcopenia
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms
Carboplatin
Antineoplastic Agents