NCT07553520

Brief 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.

Trial Health

50
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
26mo left

Started May 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
May 2026Jul 2028

First Submitted

Initial submission to the registry

April 20, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 28, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

2.2 years

First QC Date

April 20, 2026

Last Update Submit

April 20, 2026

Conditions

Recurrent GliomaGlioblastoma Multiforme

Keywords

glutathione metabolitesdietary restriction of cysteinedietary restriction of methionineradiationsurgery

Outcome Measures

Primary Outcomes (1)

  • Change in systemic glutathione metabolites

    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.

    Baseline and up to 4 days

Secondary Outcomes (6)

  • Change in systemic glutathione metabolites

    Baseline and up to 6 days

  • Change in tumor tissue glutathione metabolites

    At time of surgical resection and up to 6 days

  • Compliance with assigned diet regimen

    Baseline and up to 6 days.

  • Safety of normal or Cysteine and methionine deprivation diet

    Up to 30 days

  • Progression-Free Survival (PFS)

    1 year

  • +1 more secondary outcomes

Study Arms (6)

Cohort A: Surgery Control

ACTIVE COMPARATOR

Participants will undergo surgery and receive a normal diet.

Other: Normal diet

Cohort A: Surgery Diet Restriction 2 days

EXPERIMENTAL

Participants will undergo surgery and receive a cysteine/methionine deprivation (CMD) diet for 2 days.

Other: Cysteine/methionine deprivation (CMD) diet for 2 days

Cohort A: Surgery Diet Restriction 4 days

EXPERIMENTAL

Participants will undergo surgery and receive a cysteine/methionine deprivation (CMD) diet for 4 days.

Other: Cysteine/methionine deprivation (CMD) diet for 4 days

Cohort B: Radiation Therapy Control

ACTIVE COMPARATOR

Participants will undergo radiation therapy and receive a normal diet.

Other: Normal diet

Cohort B: Radiation Therapy 2 days

EXPERIMENTAL

Participants will undergo radiation therapy and receive a a cysteine/methionine deprivation (CMD) diet for 2 days.

Other: Cysteine/methionine deprivation (CMD) diet for 2 days

Cohort B: Radiation Therapy 4 days

EXPERIMENTAL

Participants will undergo radiation therapy and receive a a cysteine/methionine deprivation (CMD) diet for 4 days.

Other: Cysteine/methionine deprivation (CMD) diet for 4 days

Interventions

Normal dietOTHER

Participants receive normal diet.

Cohort A: Surgery ControlCohort B: Radiation Therapy Control
Cysteine/methionine deprivation (CMD) diet for 2 daysOTHER

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

Cohort A: Surgery Diet Restriction 2 daysCohort B: Radiation Therapy 2 days
Cysteine/methionine deprivation (CMD) diet for 4 daysOTHER

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

Cohort A: Surgery Diet Restriction 4 daysCohort B: Radiation Therapy 4 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina at Chapel Hill, Department of Radiation Oncology

Chapel Hill, North Carolina, 27514, United States

Location

Related Links

MeSH Terms

Conditions

GlioblastomaGlioma

Interventions

CysteineDiet

Condition Hierarchy (Ancestors)

AstrocytomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Amino Acids, SulfurSulfur CompoundsOrganic ChemicalsSulfhydryl CompoundsAmino Acids, NeutralAmino AcidsAmino Acids, Peptides, and ProteinsNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Dominique Higgins, MD, PhD

    UNC Lineberger Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2026

First Posted

April 28, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

April 28, 2026

Record last verified: 2026-04

Locations

US(1)