Immunonutrition to Reduce Toxicities in Non-Small Cell Lung Cancer

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

Interventions

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.

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.

RADIATION

Radiation Therapy

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

DRUG

Chemotherapy

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

OTHER

Quality of life (EORTC-QLQ-30)

Participants will undergo pre- and post-treatment assessments.

OTHER

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

Participants will undergo pre- and post-treatment assessments.

OTHER

Mindfulness Questionnaire (FFMQ)

Participants will undergo pre- and post-treatment assessments.

Sponsors & Collaborators

• Nestle Health Science

  collaborator INDUSTRY

• H. Lee Moffitt Cancer Center and Research Institute

  lead OTHER

Principal Investigators

• Lary A. Robinson, M.D. · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-07-31

Primary Completion

2022-09-30

Completion

2023-09-30

FDA Drug

Yes

Countries

• United States

Study Locations