Evaluating body composition's impact on chemotherapy toxicity in lung cancer patients
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 is testing how body composition affects the side effects of chemotherapy in patients with advanced lung cancer to help improve their treatment experience.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 132 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Instituto Nacional de Cancerologia de Mexico Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Mexico City) |
| Trial ID | NCT02734069 on ClinicalTrials.gov |
What this trial studies
This observational study investigates how fat-free mass and other clinical and biochemical parameters relate to the toxicity experienced by patients undergoing treatment with Carboplatin and Paclitaxel for advanced Non-Small Cell Lung Cancer (NSCLC). It aims to understand the role of body composition in predicting adverse effects of chemotherapy, particularly in a population where malnutrition and sarcopenia are prevalent. By analyzing these associations, the study seeks to improve treatment outcomes and quality of life for patients with advanced lung cancer.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with Stage IV NSCLC who are eligible for first-line treatment with Carboplatin and Paclitaxel.
Not a fit: Patients with renal impairment, uncontrolled blood pressure, or other significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized chemotherapy dosing and improved management of toxicity in lung cancer patients.
How similar studies have performed: Previous studies have indicated a correlation between body composition and chemotherapy toxicity, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Mexico City
- Instituto Nacional de Cancerologia — Mexico City, Mexico (Recruiting)
Study contacts
- Principal investigator: Oscar Arrieta, MD, MSc — Instituto Nacional de Cancerologia, Columbia
- Study coordinator: Oscar Arrieta, MD, M Sc
- Email: ogar@unam.mx
- Phone: 015556280400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.