WithdrawnPhase 2NCT03628144

Immunonutrition to Reduce Toxicities in Non-Small Cell Lung Cancer

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.

Checked against the public recordLast updated Sep 10, 2020 · Source: ClinicalTrials.gov

StatusWithdrawn
PhasePhase 2
U.S. locations1
SponsorH. Lee Moffitt Cancer Center and Research Institute
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Study overview

What this study is about

Purpose
Supportive Care
Study type
Interventional
Phase
Phase 2
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Interventions being studied
Dietary Supplement: Impact® Advanced Recovery; Dietary Supplement: Boost® High Protein; Radiation: Radiation Therapy; Drug: Chemotherapy; Other: Quality of life (EORTC-QLQ-30); Other: Evaluation of Cognitive Function (FACT-Cog, v. 3.0); Other: Mindfulness Questionnaire (FFMQ)
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Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

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Study sites

U.S. locations

  • H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 10, 2020. Always confirm current availability with the study team.

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