Exploring the Effects of a Nutritional Supplement During Immunotherapy or Combination of Immunotherapy and Chemotherapy in Non-small Cell Lung Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Disease control rate
研究概览
简要总结
People with non-small cell lung cancer are at risk for nutritional deficiencies.
The purpose of this study is to find out what effects a nutritional product has on patient's response to immunotherapy or combination of immunotherapy and chemotherapy. To do this, some of the participants will get the nutritional product and some will receive a placebo (a substance that looks like the study drug but does not have any active or medicinal ingredients). A placebo is used to make the results of the study more reliable.
Participants will be randomized to any of the following treatment groups:
- Group 1 (Experimental intervention): standard intervention of immunotherapy or combination of immunotherapy and chemotherapy plus the experimental intervention nutritional product.
Group 2 (Non-experimental intervention): standard intervention of immunotherapy or combination of immunotherapy and chemotherapy plus the non-experimental intervention placebo product.
Participants will take 5 capsules each day by mouth, starting on the first day of immunotherapy with or without chemotherapy and stopping upon completion of their immunotherapy with or without chemotherapy treatment.
Participants will complete a diary of their nutritional/ placebo product intake and will undergo the following assessments:
- Physical examination.
- Height and weight.
- ECOG status (the physician will record the impact on the cancer on daily living abilities).
- Concomitant medications recording.
- Adverse Event Assessment
- Computed tomography (CT) scan. A series of x-rays of the body from many angles that are turned into 3-dimensional pictures on a screen.
- Quality of life questionnaires.
- Blood collection
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Disease control rate
时间窗: Upon completion of 4 cycles of treatment (each cycle is 21-days)
Disease control rate is defined as the sum of patients with a complete response, partial response or stable disease via RECIST v.1.1 or iRECIST after 4-cycles of immunotherapy or a combination of chemotherapy and immunotherapy.
次要结局
- Change in Serum CRP(Upon completion of 4 cycles of chemotherapy (each cycle is 21 days))
- Change in skeletal muscle mass and adipose tissue(Upon completion of 4 cycles of chemotherapy (each cycle is 21 days))
- Changes in Quality of Life via Taste and Smell Survey(Questionnaire will be administered at cycle 1 day 1, cycle 3 day 1 (each cycle is 21 days) and at the end of treatment (within 30 days of last dose).)
- Systemic therapy-induced toxicities(On day 1 of each treatment cycle (each cycle is 21 days) and at the end of treatment visit (within 30 days of last dose))
- 1-year survival(Analysis will occur once 1-year survival data has been collected for all study participants.)
- Change in Fatty Acid Incorporation and Omega-3 Index(On day 1 of each treatment cycle (each cycle is 21 days) and at the end of treatment visit (within 30 days of last dose))
- Disease Control Rate after 2 cycles(Upon completion of 2 cycles of treatment (each cycle is 21-days))
- Progression-free survival(Analysis will occur once 1-year survival data has been collected for all study participants.)
- Change in Serum Albumin(Upon completion of 4 cycles of chemotherapy (each cycle is 21 days))
- Changes in Quality of Life via PROMIS Global Health Scale(Questionnaire will be administered at cycle 1 day 1, cycle 3 day 1 (each cycle is 21 days) and at the end of treatment (within 30 days of last dose).)
- Changes in Quality of Life via FAACT(Questionnaire will be administered at cycle 1 day 1, cycle 3 day 1 (each cycle is 21 days) and at the end of treatment (within 30 days of last dose).)
- Changes in Quality of Life via PROMIS Physical Function Short Form(Questionnaire will be administered at cycle 1 day 1, cycle 3 day 1 (each cycle is 21 days) and at the end of treatment (within 30 days of last dose).)