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

Launched by INSTITUTO NACIONAL DE CANCEROLOGIA DE MEXICO · Apr 5, 2016

Keywords

ClinConnect Summary

This clinical trial is studying how body composition, particularly the amount of fat-free mass (which includes muscles and organs), affects the side effects that patients experience when treated with a combination of two chemotherapy drugs, carboplatin and paclitaxel, for advanced lung cancer. The researchers want to see if having more fat-free mass can help reduce the toxicity (or harmful side effects) of the treatment in patients diagnosed with Stage IV non-small cell lung cancer (NSCLC).

To join the study, participants must be adults between the ages of 65 and 74 who are starting treatment with carboplatin and paclitaxel. They should be in fairly good health, with a performance status rating of 0 to 2 (meaning they can carry out daily activities with little to no assistance) and have normal kidney and liver function. Participants can expect regular check-ups and monitoring during the trial to track their health and any side effects from the treatment. It's important to note that patients with certain health issues, like severe kidney problems, high blood pressure, or uncontrolled diabetes, will not be eligible to participate. This trial aims to improve our understanding of how different body compositions can affect cancer treatment outcomes, which could lead to better care for patients in the future.

Gender

ALL

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)