Gut-Liver-Muscle Axis in Cancer Cachexia
The Gut-Liver-Muscle Axis in Patients With Head and Neck Cancer Who Experience Weight Loss: Influence of Preoperative Nutritional Supplementation
The purpose of this study is to determine if consuming a nutritional supplement before surgery affects weight loss, inflammation, and muscle in people with head and neck cancer cachexia. The investigators are doing this study to learn more about weight and muscle loss in people with cancer that does not improve with just eating more calories; this condition is called cancer cachexia. Nutritional drinks created with nutrients that may reduce inflammation and help balance the body's immune system may be a promising treatment for cancer cachexia.
The primary question is if these nutritional interventions affect muscle function through the gut-liver-muscle axis, which can be thought of as a biological "three-way conversation." The gut digests food and hosts a microbiome (a community of bacteria), the liver processes these nutrients and filters toxins, and muscles use this energy. If one part struggles, it can affect the others, impacting overall energy, metabolism, and strength.
The primary goal of this study is to determine feasibility and safety.
研究概览
地位
条件
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Kristi Engle Folchert
- 电话号码：303-724-9528
- 邮箱：Kristi.EngleFolchert@cuanschutz.edu
学习地点
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Colorado
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Aurora、Colorado、美国、80045
- UCHealth University of Colorado Hospital
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接触：
- Kristi Engle Folchert
- 电话号码：303-724-9528
- 邮箱：Kristi.EngleFolchert@cuanschutz.edu
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首席研究员：
- Carissa Thomas, MD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
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Provision to sign and date the consent form.
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Stated willingness to comply with all study procedures and be available for the duration of the study.
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Willingness to adhere to the intervention regimen, including enrollment at least 15 days before scheduled surgery.
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Be a male or female aged 40-89 years.
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For persons of reproductive potential, agree to use of highly effective method(s) of contraception and negative pregnancy test, if applicable.
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Diagnosis of any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection.
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Planned standard of care surgery with curative intent for squamous cell carcinoma. Only major surgery will be included with major surgery defined as any free flap reconstruction, any regional flap reconstruction (including pec major, submental flap, and supraclavicular artery island flap), oral composite resection, oropharyngectomy, total laryngectomy, maxillectomy with or without orbital exenteration, and/or a radical neck dissection if it includes a free flap or regional flap reconstruction.
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Meets at least one of the following criteria for cancer cachexia, in addition to presence of systemic inflammation (CRP >5mg/L):
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> 5% weight loss* in the last six months or
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BMI < 20 kg/m2 on day of evaluation and > 2% weight loss* in the last six months or
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Presence of sarcopenia** on day of evaluation and > 2% weight loss* in the last six months
- Percentage weight loss calculated as: (current weight - previous weight)/previous weight × 100; may be documented or reported ** Sarcopenia defined by accepted skeletal muscle index for age and sex based on L3 CT body composition analysis or alternatively by physical exam by a clinician.
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Exclusion Criteria:
- Contraindication to consumption of Impact AR, such as pregnancy, organ transplantation, autoimmune disease, chronic immunosuppression, severe allergy to fish oil, or strict adherence to vegetarian/vegan diet, or other contraindications at the discretion of investigator.
- Gastrointestinal disorders (inflammatory bowel disease, colon or rectal cancer, previous colon or small intestine resection).
- Stage III or higher chronic kidney disease.
- History of inflammatory liver disorders including (Cirrhosis, chronic hepatitis B or C infection, primary biliary disease, acute or chronic pancreatitis).
- Active acute or chronic pancreatitis.
- Type 1 or Type 2 Diabetes not managed with insulin.
- History of chemoradiation (except preoperative immunotherapy) or patients with recurrent head and neck cancer.
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Impact AR
Participants will consume one 8.45 fl oz carton of Impact Advanced Recovery® twice daily for 15 days before surgery. The supplement contains protein, L-arginine, and omega-3 fatty acids and is administered orally or through a feeding tube. |
Impact Advanced Recovery® (Impact AR), a commercially available immunonutrition supplement. The supplement contains protein, L-arginine, and omega-3 fatty acids and is designed to provide nutritional support and modulate inflammation. Participants may consume the supplement orally or through a feeding tube. |
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有源比较器：Active Comparator Arm
Participants will consume one 8 fl oz carton of Boost® High Protein mixed with one scoop (6 g) of Beneprotein® twice daily for 15 days before surgery. The supplement is calorie- and protein-matched to the experimental intervention and may be administered orally or through a feeding tube. |
Calorie- and protein-matched nutritional supplement consisting of Boost® High Protein (8 fl oz) mixed with one scoop (6 g) of Beneprotein®. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Study feasibility of nutritional interventions before head and neck cancer surgery.
大体时间：24 months
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Recruitment (50% consented): Percentage of eligible patients enrolled within the planned timeframe (based on projected monthly accrual). Adherence (80% of participants): Proportion of participants consuming ≥50% of prescribed Impact AR or Control Drink doses over 15 days. Specimen Collection (70% of participants): Percentage of participants providing all specimens (excluding optional stool specimens). Completion (70% of participants): Percentage of participants with complete handgrip strength measurements at all time points (baseline, post-op, post-RT). |
24 months
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Study safety of nutritional interventions before head and neck cancer surgery.
大体时间：24 months
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Safety and Tolerability: Incidence of adverse events related to nutritional supplement (e.g., refeeding syndrome). Rate of discontinuation due to intolerance or adverse events. |
24 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Evaluate the impact of preoperative nutritional support on preservation of muscle quality and function in HNCC patients after primary cancer treatment
大体时间：24 months
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Preservation of hand grip strength from baseline (Day 0) to final assessment (post-RT Day 180) between control and experimental groups |
24 months
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Evaluate the impact of preoperative nutritional support on preservation of muscle quality and function in HNCC patients after primary cancer treatment
大体时间：60 months
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Preservation of muscle mass (SMI) on CT imaging from baseline (Day 0) to final assessment (post-RT Day 180) between control and experimental groups. Preservation of muscle quality (intramuscular adipose tissue (IMAT)) on CT imaging from baseline (Day 0) to final assessment (post-RT Day 180) between control and experimental groups. |
60 months
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Determine if liver function is altered after preoperative nutritional intervention
大体时间：60 months
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Change in overall plasma bile acid concentration (from research blood sample) from baseline (Day 0) to surgery between control and experimental groups. Change in primary: secondary bile acid ratio from baseline to surgery between control and experimental groups. |
60 months
|
合作者和调查者
调查人员
- 首席研究员：Carissa M Thomas, MD PhD、UCHealth University of Colorado Cancer Center
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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