Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

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.

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.

The intervention drink Impact® will be ingested every two weeks since usually chemotherapy is delivered concurrently with radiation therapy in 2 week cycles. For patients who are placed on weekly or every 4 weeks chemotherapy dosing schedules, the treatment and control supplements will still be given every two weeks.

Impact® Advanced Recovery

The control supplement drink Boost® will be ingested every two weeks since usually chemotherapy is delivered concurrently with radiation therapy in 2 week cycles. For patients who are placed on weekly or every 4 weeks chemotherapy dosing schedules, the treatment and control supplements will still be given every two weeks.

Boost® High Protein

Standard of Care: Weekly radiation therapy as already planned for each participant, at Moffitt clinic visits.

Radiation Therapy

Standard of Care: Chemotherapy as already planned for each participant.

Chemotherapy

Participants will undergo pre- and post-treatment assessments.

Quality of life (EORTC-QLQ-30)

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

Mindfulness Questionnaire (FFMQ)

Lary A. Robinson, M.D.

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.

Randomized open-label, medical and radiation oncologist-blinded.

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)

Overall toxicity from therapy as assessed by NCI Common Toxicity Criteria for Adverse Events (CTCAE) v. 5.0 that directly correlates with toxicity from concurrent chemoradiotherapy. Based on another randomized trial using pretreatment immunonutrition, investigators want to see if this nutritional intervention will likely decrease overall chemoradiotherapy related toxicity. All toxicity and adverse events (CTCAE v.5.0) will be assessed weekly and attributed by the treating radiation oncologist and entered into the clinical trials management database OnCore for later statistical analysis. Differences in toxicity events at the end of the study in participants receiving Impact® and those receiving Boost® will be compared using two-sample t-test.

Measurement of the marked change of IL-6 that directly correlates with toxicity from concurrent chemoradiotherapy. Multiplex immunoassay will be used to determine the plasma levels of IL-6 in pg/ml as a continuous variable. Two-sample t-test for change in IL-6 at the last visit from the baseline will be compared between the two arms. Kolmogorove-Smirnov and Jarque-Bera tests will be performed to test for normality assumption on the primary endpoints prior to t-test analysis. If either test indicates a violation of the normality assumption, investigators will use an appropriate rank-based Wilcoxon rank-sum test instead of t-test.

Overall survival (OS) defined as the length of time interval between the date of cancer treatment completion and the date of death due to any cause. Kaplan-Meier curves will be estimated for each arm. Log-rank test will be performed to examine the effect of Impact® vs. Boost® on measures of OS.

Progression-free survival (PFS) will be assessed using the length of time interval from the cancer treatment completion to the earlier of the first documentation of disease progression or death from any cause. Kaplan-Meier curves will be estimated for each arm. Log-rank test will be performed to examine the effect of Impact® vs. Boost® on measures of PFS.

Treatment interruptions, chemotherapy dose reduction or hospitalizations secondary to toxicity.

Rate of participant compliance, with immunonutrition regimen, according to participant diaries. Each participant will complete a compliance diary noting when each carton/bottle of the study agent is drunk and the card will be collected by the Study Coordinator at on treatment clinic visits (OTV) prior to receiving the new batch of study or control supplements.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Immunonutrition to Reduce Toxicities in Non-Small Cell Lung Cancer	NCT03628144	Non Small Cell ... NSCLC Non-small Cell ... Non-small Cell ... Non-small Cell ... NSCLC Stage III... NSCLC, Stage II...	Impact® Advance... Boost® High Pro... Radiation Thera... Chemotherapy Quality of life... Evaluation of C... Mindfulness Que...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Immunonutrition to Reduce Toxicities in Non-Small Cell Lung Cancer	NCT03628144	Non Small Cell ... NSCLC Non-small Cell ... Non-small Cell ... Non-small Cell ... NSCLC Stage III... NSCLC, Stage II...	Impact® Advance... Boost® High Pro... Radiation Thera... Chemotherapy Quality of life... Evaluation of C... Mindfulness Que...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Immunonutrition to Reduce Toxicities in Non-Small Cell Lung Cancer	NCT03628144	Non Small Cell ... NSCLC Non-small Cell ... Non-small Cell ... Non-small Cell ... NSCLC Stage III... NSCLC, Stage II...	Impact® Advance... Boost® High Pro... Radiation Thera... Chemotherapy Quality of life... Evaluation of C... Mindfulness Que...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute

Spots Global Cancer Trial Database for mindfulness questionnaire (ffmq)