Immunonutrition to Reduce Toxicities in Non-Small Cell Lung Cancer

Study 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.

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Key things to know

Main goalSupportive Care

This describes the study’s primary purpose.

What is being studiedImpact® Advanced Recovery and Boost® High Protein

Plus 5 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

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

Is enrollment open?Withdrawn

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?H. Lee Moffitt Cancer Center and Research Institute

Study sponsor

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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How this study is categorized

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

Cancer type

Non-small cell lung cancer (NSCLC)→

Treatment approach

Chemotherapy→Radiation therapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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.

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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