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)
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Incidence of Treatment Related Adverse Events Per Study Arm
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
盲法说明
Randomized open-label, medical and radiation oncologist-blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Life expectancy >3 months.
- •No esophagitis within 90 days.
排除标准
- •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 <
- •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 >
- •Use of IL-6 inhibitors (tocilizumab or siltuximab) within last 6 months.
研究组 & 干预措施
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.
干预措施: Impact® Advanced Recovery (Dietary Supplement)
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.
干预措施: Radiation Therapy (Radiation)
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.
干预措施: Chemotherapy (Drug)
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.
干预措施: Quality of life (EORTC-QLQ-30) (Other)
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.
干预措施: Evaluation of Cognitive Function (FACT-Cog, v. 3.0) (Other)
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.
干预措施: Mindfulness Questionnaire (FFMQ) (Other)
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.
干预措施: Boost® High Protein (Dietary Supplement)
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.
干预措施: Radiation Therapy (Radiation)
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.
干预措施: Chemotherapy (Drug)
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.
干预措施: Quality of life (EORTC-QLQ-30) (Other)
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.
干预措施: Evaluation of Cognitive Function (FACT-Cog, v. 3.0) (Other)
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.
干预措施: Mindfulness Questionnaire (FFMQ) (Other)
结局指标
主要结局
Incidence of Treatment Related Adverse Events Per Study Arm
时间窗: Up to 48 months
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.
Change in Plasma Levels of IL-6 Per Study Arm
时间窗: Up to 48 months
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.
次要结局
- Progression-free Survival (PFS)(Up to 2 years)
- Rate of Treatment Changes or Interruptions Per Study Arm(Up to 2 years)
- Overall Survival (OS) 9OS)(Up to 2 years)
- Rate of Participant Regimen Compliance Per Study Arm(Up to 2 years)