Immunonutrition to Reduce Toxicities in Non-Small Cell Lung Cancer

NCT03628144 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: MCC-19505
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to 48 months

• 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.

  Up to 48 months

Secondary Outcomes (4)

• Overall Survival (OS) 9OS)

  Up to 2 years

• Progression-free Survival (PFS)

  Up to 2 years

• Rate of Treatment Changes or Interruptions Per Study Arm

  Up to 2 years

• Rate of Participant Regimen Compliance Per Study Arm

  Up to 2 years

Study Arms (2)

A: Intervention Group - Impact®

EXPERIMENTAL

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; 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)

B: Control Group - Boost®

ACTIVE COMPARATOR

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; 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)

Interventions

Impact® Advanced Recovery DIETARY_SUPPLEMENT

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.

Also known as: Nutritional supplement

A: Intervention Group - Impact®

Boost® High Protein DIETARY_SUPPLEMENT

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.

Also known as: Nutritional supplement

B: Control Group - Boost®

Radiation Therapy RADIATION

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

Also known as: Radiotherapy

A: Intervention Group - Impact®; B: Control Group - Boost®

Chemotherapy DRUG

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

Also known as: Standard of Care

A: Intervention Group - Impact®; B: Control Group - Boost®

Quality of life (EORTC-QLQ-30) OTHER

Participants will undergo pre- and post-treatment assessments.

Also known as: Questionnaire

A: Intervention Group - Impact®; B: Control Group - Boost®

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

Participants will undergo pre- and post-treatment assessments.

Also known as: Questionnaire

A: Intervention Group - Impact®; B: Control Group - Boost®

Mindfulness Questionnaire (FFMQ) OTHER

Participants will undergo pre- and post-treatment assessments.

Also known as: Questionnaire

A: Intervention Group - Impact®; B: Control Group - Boost®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Nestle Health Science: collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Dietary Supplements; Radiotherapy; Drug Therapy; Standard of Care; Quality of Life; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Therapeutics; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms

Study Officials

• Lary A. Robinson, M.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Randomized open-label, medical and radiation oncologist-blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2018
• First Posted: August 14, 2018
• Study Start: July 1, 2020
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2023
• Last Updated: September 10, 2020

Record last verified: 2020-09

Locations

US (1)