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.
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 0-2.
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)
Single group
Methionine-Reduced Diet
Other interventionNormal diet days 1-3 and 8, Methionine-Reduced Diet days 4-7, standard of care cancer treatment initiation on day 8.
Feasibility of Patient Adherence to Diet
Describe the feasibility of patients' ability to adhere to a methionine-reduced diet
Safety and Tolerability of Diet
Number of subjects who experience Grade 3 or greater Adverse Events related to methionine-reduced diet per Clinical Trial Common Terminology Criteria for Adverse Events
Correlative Biomarker changes
measure changes in serum methionine levels
Change in Quality of Life
Changes in quality of life during intervention per EORTC QLQ-C30 questionnaire.
Click on the lead sponsor to view all of their trials.
