NCT07628634招募中1 期
Feasibility Study on the Effect of a Methionine-Reduced Diet on Serum Levels in Patients With Solid Tumors
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Feasibility of Patient Adherence to Diet
研究概览
简要总结
This is a pilot clinical trial determining the effect of a Methionine-reduced diet on serum levels in subjects with solid tumors. These are subjects who will receive systemic standard of care cancer therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age: Subjects must be 18 years of age or older.
- •Diagnosis: Has a diagnosis of metastatic, recurrent, or unresectable solid tumors.
- •Life Expectancy: Subjects must have an expected life expectancy of at least 3 months.
- •Performance Status: Subjects must have an ECOG performance status of 0-
- •Organ Function: Subjects must have adequate organ function, as determined by the investigator through review of standard labs.
- •Pregnancy and Contraception: Women of childbearing potential (WOCBP) must have a negative pregnancy test within 7 days prior to study enrollment and must agree to use adequate contraception throughout the study period and for 30 days after the last dose of study treatment. Female patients who are considered not to be of childbearing potential must have a history of being postmenopausal (with a minimum of 1 year without menses), tubal ligation, or hysterectomy.
- •Dietary Compliance: Subjects must be willing and able to comply with the methionine-reduced diet as prescribed by the study protocol.
- •Informed Consent: Subjects or Legally Authorized Representatives (LAR) must provide written informed consent prior to any study-specific procedures, indicating that they understand the purpose of the study and are willing to comply with its requirements.
- •Able to receive systemic standard of care cancer therapy.
- •Additional criteria specifically for the glioma population:
- •Diagnosis: Histopathological proven diagnosis: a) newly diagnosed grade 2-3 glioma or b) all grades for recurrent glioma.
- •Treatment: Subjects must be able to receive radiation therapy and/or chemotherapy as a part of their treatment.
排除标准
- •Brain Metastases: Subjects with uncontrolled or symptomatic brain metastases. Subjects with brain metastases that have been treated, are asymptomatic, and patients who require steroids are eligible.
- •Significant Clinical Illness: Subjects with uncontrolled significant clinical illnesses, including but not limited to: a) Active infections requiring systemic therapy. b) Severe cardiovascular conditions such as recent myocardial infarction (within 6 months), uncontrolled angina, congestive heart failure (NYHA class III or IV), or significant arrhythmias. (c) Uncontrolled diabetes.
- •Significant Amino Acid/Metabolic Illnesses: Subjects with severe or inherited illnesses that affect metabolism of amino acids or disrupt nutrient absorption, including but not limited to: a) Severe liver disease, such as cirrhosis or severe hepatic insufficiency, that may have compromised ability to metabolize amino acids. b) Inherited metabolic disorders, such as homocystinuria or other disorders affecting sulfur amino acid metabolism, that may have potential metabolic imbalances. c) Severe gastrointestinal disorders, such as active inflammatory bowel disease (IBD), short bowel syndrome, or other conditions that significantly impair nutrient absorption, that may lead to nutritional deficiencies and gastrointestinal complications.
- •Recent Surgery: Major surgery within 4 weeks of randomization (biopsies are acceptable per investigator judgement)
- •Concurrent Malignancies: Subjects with another malignancy that requires active treatment during the study period or is expected to interfere with the study intervention.
- •Pregnancy or Lactation: Female subjects who are pregnant or breastfeeding.
- •Malnutrition: Subjects with severe malnutrition or significant nutritional deficiencies per investigator's discretion.
- •Substance Abuse: Subjects with a history of substance abuse or dependency within the past 6 months that, in the opinion of the investigator, would interfere with adherence to study requirements.
- •Subjects with chronic kidney disease with advanced stages 3b or higher.
- •Psychiatric Disorders: Subjects with psychiatric disorders that would interfere with the ability to give informed consent or adhere to study requirements per investigator judgment.
- •Subjects with known allergies or intolerances to low-methionine foods.
- •Subjects with any medical or surgical conditions that, in the opinion of the investigator, would make adherence to the methionine-reduced diet unsafe or impractical.
研究组 & 干预措施
Single Arm: Methionine-Reduced Diet
Experimental
干预措施: Methionine-Reduced Diet (Other)
结局指标
主要结局
Feasibility of Patient Adherence to Diet
时间窗: 8 days
Describe the feasibility of patients' ability to adhere to a methionine-reduced diet
次要结局
未报告次要终点
研究者
Zhaohui Liao Arter
Medical Oncologist | Assistant Clinical Professor
University of California, Irvine
研究点 (1)
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