Immunonutrition to Reduce Toxicities in Non-Small Cell Lung Cancer

• ClinicalTrials.gov Identifier: NCT03628144
• Recruitment Status: Withdrawn
• First Posted: August 14, 2018
• Last Update Posted: September 10, 2020
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborator: Nestle Health Science
• Information provided by (Responsible Party): H. Lee Moffitt Cancer Center and Research Institute

Study Description

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.

Condition or disease	Intervention/treatment	Phase
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	Dietary Supplement: Impact® Advanced Recovery; Dietary Supplement: Boost® High Protein; 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)	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Masking Description: Randomized open-label, medical and radiation oncologist-blinded.
• Primary Purpose: Supportive Care
• 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)
• Estimated Study Start Date: July 2020
• Estimated Primary Completion Date: September 2022
• Estimated Study Completion Date: September 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: A: Intervention Group - Impact®; 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.	Dietary Supplement: Impact® Advanced Recovery; 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.; Other Name: Nutritional supplement; Radiation: Radiation Therapy; Standard of Care: Weekly radiation therapy as already planned for each participant, at Moffitt clinic visits.; Other Name: Radiotherapy; Drug: Chemotherapy; Standard of Care: Chemotherapy as already planned for each participant.; Other Name: Standard of Care; Other: Quality of life (EORTC-QLQ-30); Participants will undergo pre- and post-treatment assessments.; Other Name: Questionnaire; Other: Evaluation of Cognitive Function (FACT-Cog, v. 3.0); Participants will undergo pre- and post-treatment assessments.; Other Name: Questionnaire; Other: Mindfulness Questionnaire (FFMQ); Participants will undergo pre- and post-treatment assessments.; Other Name: Questionnaire
Active Comparator: B: Control Group - Boost®; 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.	Dietary Supplement: Boost® High Protein; 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.; Other Name: Nutritional supplement; Radiation: Radiation Therapy; Standard of Care: Weekly radiation therapy as already planned for each participant, at Moffitt clinic visits.; Other Name: Radiotherapy; Drug: Chemotherapy; Standard of Care: Chemotherapy as already planned for each participant.; Other Name: Standard of Care; Other: Quality of life (EORTC-QLQ-30); Participants will undergo pre- and post-treatment assessments.; Other Name: Questionnaire; Other: Evaluation of Cognitive Function (FACT-Cog, v. 3.0); Participants will undergo pre- and post-treatment assessments.; Other Name: Questionnaire; Other: Mindfulness Questionnaire (FFMQ); Participants will undergo pre- and post-treatment assessments.; Other Name: Questionnaire

Outcome Measures

Primary Outcome Measures :

1. Incidence of Treatment Related Adverse Events Per Study Arm [ Time Frame: Up to 48 months ]
   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.
2. Change in Plasma Levels of IL-6 Per Study Arm [ Time Frame: Up to 48 months ]
   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.

Secondary Outcome Measures :

1. Overall Survival (OS) 9OS) [ Time Frame: Up to 2 years ]
   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.
2. Progression-free Survival (PFS) [ Time Frame: Up to 2 years ]
   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.
3. Rate of Treatment Changes or Interruptions Per Study Arm [ Time Frame: Up to 2 years ]
   Treatment interruptions, chemotherapy dose reduction or hospitalizations secondary to toxicity.
4. Rate of Participant Regimen Compliance Per Study Arm [ Time Frame: Up to 2 years ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Florida

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States, 33612

Sponsors and Collaborators

H. Lee Moffitt Cancer Center and Research Institute

Nestle Health Science

Investigators

• Principal Investigator: Lary A. Robinson, M.D.; H. Lee Moffitt Cancer Center and Research Institute

More Information

Additional Information:

Moffitt Cancer Center Clinical Trials website 

• Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
• ClinicalTrials.gov Identifier: NCT03628144
• Other Study ID Numbers: MCC-19505
• First Posted: August 14, 2018
• Last Update Posted: September 10, 2020
• Last Verified: September 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:

Immunonutrition; Radiotherapy; Unresectable; Stage IIIA-B; Lung cancer; Radiation oncology; Thoracic oncology; Epidemiology; Nutrition

Additional relevant MeSH terms:

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms