Immunonutrition to Reduce Toxicities in Non-Small Cell Lung Cancer

NCT ID: NCT03628144

Last Updated: 2020-09-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-31
• Study Completion Date: 2023-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Impact® Advanced Recovery

Intervention Type: 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.

Radiation Therapy

Intervention Type: RADIATION

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

Chemotherapy

Intervention Type: DRUG

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

Quality of life (EORTC-QLQ-30)

Intervention Type: OTHER

Participants will undergo pre- and post-treatment assessments.

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

Intervention Type: OTHER

Participants will undergo pre- and post-treatment assessments.

Mindfulness Questionnaire (FFMQ)

Intervention Type: OTHER

Participants will undergo pre- and post-treatment assessments.

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.

Group Type: ACTIVE_COMPARATOR

Boost® High Protein

Intervention Type: 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.

Radiation Therapy

Intervention Type: RADIATION

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

Chemotherapy

Intervention Type: DRUG

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

Quality of life (EORTC-QLQ-30)

Intervention Type: OTHER

Participants will undergo pre- and post-treatment assessments.

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

Intervention Type: OTHER

Participants will undergo pre- and post-treatment assessments.

Mindfulness Questionnaire (FFMQ)

Intervention Type: OTHER

Participants will undergo pre- and post-treatment assessments.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Radiation Therapy

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

Intervention Type: RADIATION

Chemotherapy

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

Intervention Type: DRUG

Quality of life (EORTC-QLQ-30)

Participants will undergo pre- and post-treatment assessments.

Intervention Type: OTHER

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

Participants will undergo pre- and post-treatment assessments.

Intervention Type: OTHER

Mindfulness Questionnaire (FFMQ)

Participants will undergo pre- and post-treatment assessments.

Intervention Type: OTHER

Other Intervention Names

Nutritional supplement; Nutritional supplement; Radiotherapy; Standard of Care; Questionnaire; Questionnaire; Questionnaire

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nestle Health Science

INDUSTRY

Sponsor Role: collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lary A. Robinson, M.D.

Role: PRINCIPAL_INVESTIGATOR

H. Lee Moffitt Cancer Center and Research Institute

Locations

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Countries

United States

Other Identifiers

MCC-19505

Identifier Type: -

Identifier Source: org_study_id