Immunonutrition to Reduce Toxicities in Non-Small Cell Lung Cancer

H. Lee Moffitt Cancer Center and Research Institute

Status and phase: Withdrawn; Phase 2

Conditions: NSCLC, Stage IIIA; Non-small Cell Lung Cancer Stage IIIB; Non-small Cell Lung Cancer; Non-small Cell Lung Cancer Stage ⅢA; Non Small Cell Lung Cancer; NSCLC Stage IIIB; NSCLC

Treatments: Other: Quality of life (EORTC-QLQ-30); Drug: Chemotherapy; Other: Mindfulness Questionnaire (FFMQ); Dietary Supplement: Boost® High Protein; Dietary Supplement: Impact® Advanced Recovery; Other: Evaluation of Cognitive Function (FACT-Cog, v. 3.0); Radiation: Radiation Therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03628144

MCC-19505

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

A: Intervention Group - Impact®

Experimental group

Description:

A: Intervention Group - Standard of Care Concurrent Chemoradiotherapy (Chemotherapy + Radiation) with nutritional supplement. Impact® Advanced Recovery: Three times daily for the 5 days just prior to the start of each cycle of chemotherapy. Participants will undergo pre- and post-treatment assessments.

Treatment:

Radiation: Radiation Therapy

Other: Evaluation of Cognitive Function (FACT-Cog, v. 3.0)

Dietary Supplement: Impact® Advanced Recovery

Other: Mindfulness Questionnaire (FFMQ)

Drug: Chemotherapy

Other: Quality of life (EORTC-QLQ-30)

B: Control Group - Boost®

Active Comparator group

Description:

B: Control Group - Standard of Care Concurrent Chemoradiotherapy (Chemotherapy + Radiation) with nutritional supplement. Boost® High Protein: Identical schedule of a supplement with similar calorie and protein content, Boost® High Protein. Participants will undergo pre- and post-treatment assessments.

Treatment:

Radiation: Radiation Therapy

Other: Evaluation of Cognitive Function (FACT-Cog, v. 3.0)

Dietary Supplement: Boost® High Protein

Other: Mindfulness Questionnaire (FFMQ)

Drug: Chemotherapy

Other: Quality of life (EORTC-QLQ-30)