NCT03628144

Immunonutrition to Reduce Toxicities in Non-Small Cell Lung Cancer

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)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2020-07-01
• Primary completion: 2022-09-01
• Completion: 2023-09-01
• First posted: 2018-08-14
• Last updated: 2020-09-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study