Evaluating the Impact of Intermittent Fasting in Combination With Checkpoint Inhibitors in Patients With Non-small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 4
- 主要终点
- Feasibility of fasting mimicking diet intervention
研究概览
简要总结
The purpose of this study is to learn the effects of fasting on cancer cells while you get maintenance treatment.
详细描述
Cancer cells use an increased supply of glucose to make energy and do not have protection against fasting that normal cells do. Because of this, researchers would like to study how fasting may help immunotherapy target cancer cells. Initial studies suggest that fasting may decrease the side effects of immunotherapy and increase the chances of your cancer responding to the immunotherapy. Patient populations will have non-small cell lung cancer in which pembrolizumab have been recommended to treat the cancer as part of standard care
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
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
- •18 years at the time of informed consent
- •Ability to provide written informed consent and HIPAA authorization.
- •Eastern cooperative group (ECOG) performance status of 0 to 2
- •Newly diagnosed histologically or cytologically confirmed stage IV Non-Small Cell Lung Cancer (NSCLC). Patients with locally advanced NSCLC that are not candidates for definitive therapy but are candidates for trial are allowed per investigator discretion.
- •BMI 19 kg/m2
- •Patients should be enrolled prior to starting standard of care immunotherapy for the treatment of stage IV NSCLC. Patients should be on PD (L)1 inhibitor alone (i.e., with PD-L1 expression 50%) in the metastatic setting. The investigators will allow single agent pembrolizumab only as the checkpoint inhibitor.
- •Patients requiring palliative radiation or definitive radiation to an oligometastatic disease prior to the initiation of single agent checkpoint inhibitors are allowed once radiation has been completed and patients have recovered from toxicities.
排除标准
- •Self-reported weight loss of > 10% in the 6 weeks prior to study entry
- •History of symptomatic hypoglycemia or uncontrolled diabetes
- •Prior therapies with inhibitors of insulin growth factor I(IGF-1) such as Linsitinib or Picropodophyllin
- •Concurrent use of somatostatin
- •Concurrent use of immunosuppressive medications including sirolimus, tacrolimus, mycophenolate mofetil, azathioprine, prednisone, dexamethasone, or cyclosporine
- •Significant food allergies which would make the subject unable to consume the food provided.
- •History or current evidence of any uncontrolled medical or psychiatric condition, therapy that may confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the participating subject as deemed by the treating investigator.
- •Pregnant or lactating females are not eligible.
研究组 & 干预措施
FMD
Plant based diet program.
干预措施: FMD (Dietary Supplement)
FMD
Plant based diet program.
干预措施: Regular Diet Plus FMD (Combination Product)
Regular Diet
Patients will eat a RD with the first 3 cycles, then receive 3 cycles of FMD as they continue cycles 4-6.
干预措施: Regular Diet Plus FMD (Combination Product)
结局指标
主要结局
Feasibility of fasting mimicking diet intervention
时间窗: Through study completion up to 2 years.
Feasibility will be defined as the proportion of the patients who can finish the 3 cycles FMD without serious adverse events. The investigators define FMD as being a feasible intervention in NSCLC receiving checkpoint inhibitors if 70% of patients on study complete 3 cycles of FMD.
Compliance
时间窗: Through study completion up to 2 years.
Compliance will be measured by analysis of daily food diaries at the end of each FMD cycle.
次要结局
- Immune Mediated Toxicities(Through study completion up to 2 years.)
- Overall response rate (ORR)(Through study completion up to 2 years.)
- Disease control rate (DCR)(Through study completion up to 2 years.)
- Progression Free Survival (PFS)(Through study completion up to 2 years.)
- Functional Assessment of Cancer Therapy-Lung-(FACT-L)(Through study completion up to 2 years.)
- European Organization for the Research and Treatment of Cancer Quality of Life -(EORTC QLQ-C30)(Through study completion up to 2 years.)