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Dietary Cysteine and Methionine Deprivation (CMD) in Glioma Patients

NCT07553520 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2026-04-28

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Normal diet

Participants receive normal diet.

OTHER

Cysteine/methionine deprivation (CMD) diet for 2 days

Participants receive cysteine/methionine deprivation (CMD) diet for 2 days.

OTHER

Cysteine/methionine deprivation (CMD) diet for 4 days

receive cysteine/methionine deprivation (CMD) diet for 4 days.

Sponsors & Collaborators

  • UNC Lineberger Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Dominique Higgins, MD, PhD · UNC Lineberger Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2028-07-31
Completion
2028-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07553520 on ClinicalTrials.gov