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Immunonutrition to Reduce Toxicities in Non-Small Cell Lung Cancer

Primary Purpose

Non Small Cell Lung Cancer, NSCLC, Non-small Cell Lung Cancer

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Impact® Advanced Recovery
Boost® High Protein
Radiation Therapy
Chemotherapy
Quality of life (EORTC-QLQ-30)
Evaluation of Cognitive Function (FACT-Cog, v. 3.0)
Mindfulness Questionnaire (FFMQ)
Sponsored by
H. Lee Moffitt Cancer Center and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Non Small Cell Lung Cancer focused on measuring Immunonutrition, Radiotherapy, Unresectable, Stage IIIA-B, Lung cancer, Radiation oncology, Thoracic oncology, Epidemiology, Nutrition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • H. Lee Moffitt Cancer Center and Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A: Intervention Group - Impact®

B: Control Group - Boost®

Arm 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.

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.

Outcomes

Primary Outcome Measures

Incidence of Treatment Related Adverse Events Per Study Arm
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.
Change in Plasma Levels of IL-6 Per Study Arm
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

Overall Survival (OS) 9OS)
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)
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.
Rate of Treatment Changes or Interruptions Per Study Arm
Treatment interruptions, chemotherapy dose reduction or hospitalizations secondary to toxicity.
Rate of Participant Regimen Compliance Per Study Arm
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.

Full Information

First Posted
August 9, 2018
Last Updated
September 9, 2020
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
Nestle Health Science
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1. Study Identification

Unique Protocol Identification Number
NCT03628144
Brief Title
Immunonutrition to Reduce Toxicities in Non-Small Cell Lung Cancer
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Funding unavailable
Study Start Date
July 2020 (Anticipated)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
Nestle Health Science

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
Immunonutrition, Radiotherapy, Unresectable, Stage IIIA-B, Lung cancer, Radiation oncology, Thoracic oncology, Epidemiology, Nutrition

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
Randomized open-label, medical and radiation oncologist-blinded.
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A: Intervention Group - Impact®
Arm Type
Experimental
Arm 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.
Arm Title
B: Control Group - Boost®
Arm Type
Active Comparator
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Impact® Advanced Recovery
Other Intervention Name(s)
Nutritional supplement
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Boost® High Protein
Other Intervention Name(s)
Nutritional supplement
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Other Intervention Name(s)
Radiotherapy
Intervention Description
Standard of Care: Weekly radiation therapy as already planned for each participant, at Moffitt clinic visits.
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Other Intervention Name(s)
Standard of Care
Intervention Description
Standard of Care: Chemotherapy as already planned for each participant.
Intervention Type
Other
Intervention Name(s)
Quality of life (EORTC-QLQ-30)
Other Intervention Name(s)
Questionnaire
Intervention Description
Participants will undergo pre- and post-treatment assessments.
Intervention Type
Other
Intervention Name(s)
Evaluation of Cognitive Function (FACT-Cog, v. 3.0)
Other Intervention Name(s)
Questionnaire
Intervention Description
Participants will undergo pre- and post-treatment assessments.
Intervention Type
Other
Intervention Name(s)
Mindfulness Questionnaire (FFMQ)
Other Intervention Name(s)
Questionnaire
Intervention Description
Participants will undergo pre- and post-treatment assessments.
Primary Outcome Measure Information:
Title
Incidence of Treatment Related Adverse Events Per Study Arm
Description
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.
Time Frame
Up to 48 months
Title
Change in Plasma Levels of IL-6 Per Study Arm
Description
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.
Time Frame
Up to 48 months
Secondary Outcome Measure Information:
Title
Overall Survival (OS) 9OS)
Description
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.
Time Frame
Up to 2 years
Title
Progression-free Survival (PFS)
Description
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.
Time Frame
Up to 2 years
Title
Rate of Treatment Changes or Interruptions Per Study Arm
Description
Treatment interruptions, chemotherapy dose reduction or hospitalizations secondary to toxicity.
Time Frame
Up to 2 years
Title
Rate of Participant Regimen Compliance Per Study Arm
Description
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.
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lary A. Robinson, M.D.
Organizational Affiliation
H. Lee Moffitt Cancer Center and Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Immunonutrition to Reduce Toxicities in Non-Small Cell Lung Cancer

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