Clinical trial NCT03628144: Immunonutrition to Reduce Toxicities in Non-Small Cell Lung Cancer
Official title: 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)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
NSCLC
Non-small Cell Lung Cancer
Non-small Cell Lung Cancer Stage IIIB
Non-small Cell Lung Cancer Stage ⅢA
NSCLC Stage IIIB
NSCLC, Stage IIIA
Keywords: Immunonutrition
Radiotherapy
Unresectable
Stage IIIA-B
Lung cancer
Radiation oncology
Thoracic oncology
Epidemiology
Nutrition
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: Nestle Health Science
First posted: 2018-08-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Incidence of Treatment Related Adverse Events Per Study Arm
timeFrame: Up to 48 months
measure: Change in Plasma Levels of IL-6 Per Study Arm
timeFrame: Up to 48 months
Secondary outcomes:
measure: Overall Survival (OS) 9OS)
timeFrame: Up to 2 years
measure: Progression-free Survival (PFS)
timeFrame: Up to 2 years
measure: Rate of Treatment Changes or Interruptions Per Study Arm
timeFrame: Up to 2 years
measure: Rate of Participant Regimen Compliance Per Study Arm
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Lary A. Robinson, M.D.
role: PRINCIPAL_INVESTIGATOR
References: