Dietary Cysteine and Methionine Deprivation (CMD) in Glioma Patients
April 20, 2026 updated by: UNC Lineberger Comprehensive Cancer Center
A Pilot Study Examining Dietary Restriction of Sulfur Containing Amino Acids by Cysteine and Methionine Deprivation (CMD) in Glioma Patients
This pilot study looks at how certain diet changes affect the body in patients with recurrent brain tumors (glioma) who are planning to have standard treatment like radiation or surgery. Up to 30 patients will be randomly assigned to either a regular diet or a special diet that limits two nutrients (cysteine and methionine) for 2, 4, or 7 days before their treatment.
Patients will be monitored for side effects using blood tests and questionnaires, and patients will keep a diary to track how well they follow the diet. Blood and urine samples will be used to see how the diet affects the body. Tumor samples (from surgery) will help researchers study how the cancer cells behave, and stool samples will be used to look at gut bacteria.
This is a randomized, blinded interventional pilot study to measure glutathione metabolite levels with a cysteine/methionine deprivation (CMD) diet in glioma patients. A menu of pre-prepared meals will be provided to subjects that consist of either a control diet or a CMD diet. The CMD diet will be implemented simultaneously in 2 cohorts of participants with recurrent glioma.
The primary objective will be to measure the metabolic state of glioblastome multiforme tumor cells through dietary restriction of the sulfur-containing amino acids (SAA), cysteine/cystine and methionine.
Patient from cohort A can later be included in Cohort B if applicable. Patients will be followed for progression free survival and overall survival for up to 1 year, or until they discontinue or are removed from the study for exploratory endpoints.
Study Overview
Status
Withdrawn
Conditions
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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North Carolina
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Chapel Hill, North Carolina, United States, 27514
- University of North Carolina at Chapel Hill, Department of Radiation Oncology
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-
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
In order to participate in this study a subject must meet all of the eligibility criteria outlined below. Eligibility must be maintained up until the point at which the subject receives treatment for the subject to be considered eligible for treatment.
Inclusion Criteria:
- Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
- Subjects is willing and able to comply with study procedures based on the judgement of the investigator.
- Age ≥ 18 years at the time of consent.
- Karnofsky Performance Status of ≥ 60 assessed at diagnosis
Exclusion Criteria:
- Active infection requiring systemic therapy.
- Any active disease that may be associated with unacceptable anesthetic/operative risk.
- Pregnant or breastfeeding
- Subjects with prior brain metastasis.
- Transfusion within 7 days of diet initiation
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Cohort A: Surgery Control
Participants will undergo surgery and receive a normal diet.
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Participants receive normal diet.
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Experimental: Cohort A: Surgery Diet Restriction 2 days
Participants will undergo surgery and receive a cysteine/methionine deprivation (CMD) diet for 2 days.
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Participants receive cysteine/methionine deprivation (CMD) diet for 2 days.
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Experimental: Cohort A: Surgery Diet Restriction 4 days
Participants will undergo surgery and receive a cysteine/methionine deprivation (CMD) diet for 4 days.
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receive cysteine/methionine deprivation (CMD) diet for 4 days.
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Active Comparator: Cohort B: Radiation Therapy Control
Participants will undergo radiation therapy and receive a normal diet.
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Participants receive normal diet.
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Experimental: Cohort B: Radiation Therapy 2 days
Participants will undergo radiation therapy and receive a a cysteine/methionine deprivation (CMD) diet for 2 days.
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Participants receive cysteine/methionine deprivation (CMD) diet for 2 days.
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Experimental: Cohort B: Radiation Therapy 4 days
Participants will undergo radiation therapy and receive a a cysteine/methionine deprivation (CMD) diet for 4 days.
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receive cysteine/methionine deprivation (CMD) diet for 4 days.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in systemic glutathione metabolites
Time Frame: Baseline and up to 4 days
|
Systemic glutathione metabolite levels in blood and urine will be assessed before and after a 2-day randomized assigned diet (normal or Cysteine and methionine deprivation (CMD)) diet.
Measurements will be obtained using laboratory assays and Magnetic resonance (MR) spectroscopy.
Analyses will be conducted overall and stratified by patients scheduled for standard-of-care (SOC) radiation therapy or surgery.
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Baseline and up to 4 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in systemic glutathione metabolites
Time Frame: Baseline and up to 6 days
|
Glutathione metabolite levels in blood and urine will be measured before and after assigned diet (normal or Cysteine and methionine deprivation (CMD)) diet.
regimen using laboratory assays and Magnetic resonance (MR) spectroscopy.
The pre-diet assessment will occur after a 2-day fast, and the post-diet assessment will occur after 4 days on the assigned diet (CMD or control).
|
Baseline and up to 6 days
|
|
Change in tumor tissue glutathione metabolites
Time Frame: At time of surgical resection and up to 6 days
|
Local tumor tissue metabolite levels will be assessed in resected glioma specimens from patients in the surgical cohort following assigned diet (normal or Cysteine and methionine deprivation (CMD) for 2 days and 4 days) diet.
regimens.
Metabolite levels will be measured using laboratory assays and Magnetic resonance (MR) spectroscopy to evaluate changes associated with acute CMD exposure.
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At time of surgical resection and up to 6 days
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Compliance with assigned diet regimen
Time Frame: Baseline and up to 6 days.
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The proportion of patients who achieve 100% compliance with their assigned diet (normal or Cysteine and methionine deprivation (CMD)) diet.
regimen will be assessed.
The numerator is the number of patients with complete diet adherence, and the denominator is the total number of patients randomized to each diet.
Compliance will be calculated separately for the 2-day and 4-day CMD regimens.
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Baseline and up to 6 days.
|
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Safety of normal or Cysteine and methionine deprivation diet
Time Frame: Up to 30 days
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Safety will be evaluated in patients receiving normal or Cysteine and methionine deprivation (CMD) 2-day or 4-day diet from randomization through 30 days after standard-of-care surgery or radiation.
Assessments will include hematology, serum chemistry, and adverse events graded per The NCI Common Terminology Criteria for Adverse Events (AE) is a descriptive terminology (CTCAE).
CTCAE is a grading (severity) scale is provided for each AE term.
Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.
Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL).
Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL.
Grade 4 Life-threatening consequences; urgent intervention indicated.
Grade 5 Death related to AE.
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Up to 30 days
|
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Progression-Free Survival (PFS)
Time Frame: 1 year
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PFS will be assessed in patients randomized to each diet regimen following surgery or radiation.
PFS is defined as the time from the start of the prescribed diet to disease progression or death from any cause, whichever occurs first.
Data will be obtained via medical record abstraction at 1 year.
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1 year
|
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Overall Survival
Time Frame: 1 year
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OS will be described for evaluable a patients randomized to each diet regimen following surgery or radiation.
OS will be defined as the time from the start of the prescribed diet to death from any cause and obtained via medical record abstraction at 1 year
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1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Dominique Higgins, MD, PhD, UNC Lineberger Comprehensive Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 (Estimated)
May 1, 2026
Primary Completion (Estimated)
July 1, 2028
Study Completion (Estimated)
July 1, 2028
Study Registration Dates
First Submitted
April 20, 2026
First Submitted That Met QC Criteria
April 20, 2026
First Posted (Actual)
April 28, 2026
Study Record Updates
Last Update Posted (Actual)
April 28, 2026
Last Update Submitted That Met QC Criteria
April 20, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Neoplasms by Histologic Type
- Neoplasms, Glandular and Epithelial
- Astrocytoma
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Glioblastoma
- Glioma
- Amino Acids, Peptides, and Proteins
- Sulfur Compounds
- Organic Chemicals
- Diet, Food, and Nutrition
- Physiological Phenomena
- Nutritional Physiological Phenomena
- Amino Acids
- Amino Acids, Sulfur
- Sulfhydryl Compounds
- Amino Acids, Neutral
- Diet
- Cysteine
Other Study ID Numbers
- LCCC2249
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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