Immunonutrition to Reduce Toxicities in Non-Small Cell Lung Cancer



Status:Not yet recruiting
Conditions:Lung Cancer, Lung Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:June 2019
End Date:June 2023

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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.
We found this trial at
1
site
12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
Principal Investigator: Lary A. Robinson, M.D.
Phone: 813-745-7363
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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mi
from
Tampa, FL
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