A Phase 2 interventional study of Impact® Advanced Recovery and Boost® High Protein in Non Small Cell Lung Cancer, NSCLC and Non-small Cell Lung Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-10.
Sponsored by H. Lee Moffitt Cancer Center and Research Institute · Phase 2, Interventional, and Supportive care
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.
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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.
Exclusion Criteria:
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 - 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)
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
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
Standard of Care: Weekly radiation therapy as already planned for each participant, at Moffitt clinic visits.
Also known as: Radiotherapy
Standard of Care: Chemotherapy as already planned for each participant.
Also known as: Standard of Care
Participants will undergo pre- and post-treatment assessments.
Also known as: Questionnaire
Participants will undergo pre- and post-treatment assessments.
Also known as: Questionnaire
Participants will undergo pre- and post-treatment assessments.
Also known as: Questionnaire
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.
Time frame: 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.
Time frame: Up to 48 months
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.
Time frame: Up to 2 years
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.
Time frame: Up to 2 years
Rate of Treatment Changes or Interruptions Per Study Arm
Treatment interruptions, chemotherapy dose reduction or hospitalizations secondary to toxicity.
Time frame: Up to 2 years
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.
Time frame: Up to 2 years
This study is withdrawn, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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H. Lee Moffitt Cancer Center and Research Institute