Immunonutrition to Reduce Toxicities in Non-Small Cell Lung Cancer

H. Lee Moffitt Cancer Center and Research Institute logo

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Withdrawn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

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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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