Feasibility Study on the Effect of a Methionine-Reduced Diet on Serum Levels in Pts w/ Solid Tumors

June 2, 2026 updated by: Zhaohui Liao Arter, University of California, Irvine

Feasibility Study on the Effect of a Methionine-Reduced Diet on Serum Levels in Patients With Solid Tumors

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Chao Family Comprehensive Cancer Center University of California, Irvine
  • Phone Number: 877-827-8839
  • Email: ucstudy@uci.edu

Study Contact Backup

  • Name: University of California Irvine Medical

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • Recruiting
        • Chao Family Comprehensive Cancer Center, University of California, Irvine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Arm: Methionine-Reduced Diet
Other: Methionine-Reduced Diet
Normal diet days 1-3 and 8, Methionine-Reduced Diet days 4-7, standard of care cancer treatment initiation on day 8.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to Diet
Time Frame: 8 days
Describe the feasibility of patients' ability to adhere to a methionine-reduced diet
8 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Tolerability of Diet
Time Frame: 43 days
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
43 days
Correlative Biomarker changes
Time Frame: 43 days
measure changes in serum methionine levels
43 days
Change in Quality of Life
Time Frame: 8 day
Changes in quality of life during intervention per EORTC QLQ-C30 questionnaire.
8 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Investigators

  • Principal Investigator: Zhaohui A Arter, MD, Chao Family Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

May 20, 2026

First Submitted That Met QC Criteria

June 2, 2026

First Posted (Actual)

June 5, 2026

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00000464
  • UCI 24-87 (Other Identifier: UCI)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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