Clinical trial · Interventional
Immunonutrition to Reduce Toxicities in Non-Small Cell Lung Cancer
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)
NCT03628144CI-TRIAL-00047096withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding unavailable
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Non-small Cell Lung Cancer Stage ⅢA | Lung Neoplasm | PROBABILISTIC | 0.70 |
| Non-small Cell Lung Cancer Stage IIIB | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| NSCLC, Stage IIIA | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| NSCLC Stage IIIB | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Boost® High Protein | Dietary Supplement | — | UNRESOLVED |
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| Evaluation of Cognitive Function (FACT-Cog, v. 3.0) | Other | — | UNRESOLVED |
| Impact® Advanced Recovery | Dietary Supplement | — | UNRESOLVED |
| Mindfulness Questionnaire (FFMQ) | Other | — | UNRESOLVED |
| Quality of life (EORTC-QLQ-30) | Other | — | UNRESOLVED |
| Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A: Intervention Group - Impact®
- 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.
- interventionNames
- Dietary Supplement: Impact® Advanced Recovery
- 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)
- type
- ACTIVE_COMPARATOR
- label
- B: Control Group - Boost®
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.