Immunonutrition to Reduce Toxicities in Non-Small Cell Lung Cancer

• Status: Withdrawn
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: Nestlé Health Science Spain; Nestle Health Science US

Criteria

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.