Immunonutrition to Reduce Toxicities in Non-Small Cell Lung Cancer

The Use of Immunonutrition to Reduce Toxicities From Concurrent Chemotherapy and Radiotherapy for Treatment of Unresectable Stage IIIA-B Non-Small Cell Lung Cancer (NSCLC)

The purpose of this study is to assess whether either or both nutrition supplements (Impact® Advanced Recovery or Boost® High Protein) ingested prior to and during concurrent chemoradiotherapy decreases toxic side effects of treatment in Stage IIIA-B non-small cell lung cancer.

Inclusion Criteria:

• Patients will be recruited from the Moffitt Cancer Center Thoracic Oncology Outpatient Clinic when identified by a thoracic oncologist that the patient will undergo all of their chemoradiotherapy at Moffitt.

  • Men and women ≥18 years of age.
  • Diagnosed with unresectable stage IIIA or IIIB non-small cell lung cancer.
  • Patients plan to undergo all cancer treatment at Moffitt Cancer Center with definitive concurrent chemotherapy and radiotherapy.
  • No prior treatment of NSCLC.
  • Able to provide informed consent.
  • Performance status 0, 1 or 2.
  • Life expectancy >3 months.
  • No esophagitis within 90 days.

Exclusion Criteria:

• Mental incompetence or chronic psychiatric disease.
• Incarcerated individuals.
• Use of antibiotics or probiotic supplements within one month of chemoradiotherapy.
• Allergy to any of the components of Impact® Advanced Recovery or Boost® High Protein.
• Pregnant female or breast-feeding. Any female patient <45 years old not using appropriate contraceptive measures during the treatment.
• Sepsis or active infection.
• Chronic renal failure stage IV (requiring protein restriction) or stage V requiring dialysis.
• Malnutrition defined as BMI <16.
• Inflammatory bowel disease (ulcerative colitis or Crohn's disease).
• Severe hepatic dysfunction (baseline prothrombin time off any anticoagulation of international normalized ratio (INR) >1.8).
• Significant digestive disease with nausea, vomiting or diarrhea, NCI Grade >1.
• Use of IL-6 inhibitors (tocilizumab or siltuximab) within last 6 months.