Actively Recruiting
Feasibility Study on the Effect of a Methionine-Reduced Diet on Serum Levels in Patients With Solid Tumors
Led by University of California, Irvine · Updated on 2026-06-05
25
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of a Methionine-reduced diet on blood serum levels in adults with various types of solid tumors who are receiving standard cancer treatments. This early phase 1 pilot trial aims to understand how this diet may impact patients undergoing systemic cancer therapy and to assess its feasibility. Participants will follow a normal diet for the first three days and on day eight, with a Methionine-reduced diet prescribed from days four to seven. Standard cancer treatment begins on day eight. The study focuses on adherence to the diet over eight days and monitors safety, tolerability, biomarker changes, and quality of life during a 43-day period. During the trial, participants will be closely monitored through lab tests and assessments to track diet adherence and health effects. Researchers will measure changes in biomarkers and quality of life, while also ensuring safety throughout the study. The total participation duration includes the initial diet period and follow-up assessments lasting up to 43 days.
CONDITIONS
Brief Title
Feasibility Study on the Effect of a Methionine-Reduced Diet on Serum Levels in Pts w/ Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of metastatic, recurrent, or unresectable solid tumors
- Expected life expectancy of at least 3 months
- ECOG performance status between 0 and 2
- Adequate organ function based on standard laboratory tests
- Women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment and agree to use contraception during and for 30 days after the study
- Women not of childbearing potential must be postmenopausal for at least 1 year, have tubal ligation, or hysterectomy
- Willing and able to comply with the Methionine-reduced diet as prescribed
- Provide written informed consent prior to study procedures
- Able to receive systemic standard of care cancer therapy
- For glioma patients: histopathological diagnosis of grade 2-3 newly diagnosed or any recurrent glioma
- Glioma patients must be able to receive radiation and/or chemotherapy
You will not qualify if you...
- Uncontrolled or symptomatic brain metastases (treated, asymptomatic brain metastases on steroids allowed)
- Uncontrolled significant clinical illnesses including active infections, severe cardiovascular conditions, or uncontrolled diabetes
- Severe or inherited amino acid or metabolic illnesses affecting amino acid metabolism or nutrient absorption
- Major surgery within 4 weeks prior to randomization (biopsies allowed)
- Concurrent malignancies requiring active treatment or interfering with study
- Pregnant or breastfeeding women
- Severe malnutrition or significant nutritional deficiencies
- Substance abuse or dependency within past 6 months interfering with study adherence
- Chronic kidney disease stage 3b or higher
- Psychiatric disorders impairing consent or adherence
- Known allergies or intolerances to low-methionine foods
- Any medical or surgical conditions making adherence to the diet unsafe or impractical
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 days
Participants follow a methionine-reduced diet on days 4 to 7 with normal diet on days 1 to 3 and day 8, when standard cancer treatment begins.
Daily visits or contacts during diet days
Duration - Up to 43 days
Participants are monitored for safety, tolerability, biomarker changes, and quality of life for up to 43 days after starting the diet.
Several follow-up visits over 43 days
Trial Site Locations
Total: 1 location
1
Chao Family Comprehensive Cancer Center, University of California, Irvine
Orange, California, United States, 92868
Actively Recruiting
Research Team
C
Chao Family Comprehensive Cancer Center University of California, Irvine
U
University of California Irvine Medical
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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