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Official title Feasibility Study on the Effect of a Methionine-Reduced Diet on Serum Levels in Pts w/ Solid Tumors
ClinicalTrials.gov ID: NCT07628634
What this study is testing
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age: people must be 18 years of age or older.
- Diagnosis: Has a diagnosis of metastatic, recurrent, or unresectable solid tumors.
- Life Expectancy: people must have an expected life expectancy of at least 3 months.
- Performance Status: people must have an ECOG performance status of 0-2.
- Organ Function: people must have adequate organ function, as determined by the investigator through review of standard labs.
You likely can't join if
- Brain Metastases: people with uncontrolled or symptomatic brain metastases. people with brain metastases that have been treated, are asymptomatic...
- Significant Clinical Illness: people with uncontrolled significant clinical illnesses, including but not limited to: a) Active infections requiring...
- Significant Amino Acid/Metabolic Illnesses: people with severe or inherited illnesses that affect metabolism of amino acids or disrupt nutrient...
- Recent Surgery: Major surgery within 4 weeks of randomization (biopsies are acceptable per investigator judgement)
- Concurrent Malignancies: people with another malignancy that requires active treatment during the study period or is expected to interfere with the...
- Pregnancy or Lactation: Female people who are pregnant or breastfeeding.
See the full eligibility criteria
- Age: people must be 18 years of age or older.
- Diagnosis: Has a diagnosis of metastatic, recurrent, or unresectable solid tumors.
- Life Expectancy: people must have an expected life expectancy of at least 3 months.
- Performance Status: people must have an ECOG performance status of 0-2.
- Organ Function: people 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...
- Dietary Compliance: people must be willing and able to comply with the methionine-reduced diet as prescribed by the study protocol.
- Informed Consent: people 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...
- 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: people must be able to receive radiation therapy and/or chemotherapy as a part of their treatment.
- Brain Metastases: people with uncontrolled or symptomatic brain metastases. people with brain metastases that have been treated, are asymptomatic, and patients who require steroids are eligible.
- Significant Clinical Illness: people with uncontrolled significant clinical illnesses, including but not limited to: a) Active infections requiring systemic therapy. b) Severe cardiovascular conditions such as recent...
- Significant Amino Acid/Metabolic Illnesses: people 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...
- Recent Surgery: Major surgery within 4 weeks of randomization (biopsies are acceptable per investigator judgement)
- Concurrent Malignancies: people with another malignancy that requires active treatment during the study period or is expected to interfere with the study intervention.
- Pregnancy or Lactation: Female people who are pregnant or breastfeeding.
- Malnutrition: people with severe malnutrition or significant nutritional deficiencies per investigator's discretion.
- Substance Abuse: people 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.
- people with chronic kidney disease with advanced stages 3b or higher.
- Psychiatric Disorders: people with psychiatric disorders that would interfere with the ability to give informed consent or adhere to study requirements per investigator judgment.
- people with known allergies or intolerances to low-methionine foods.
- people with any medical or surgical conditions that, in the opinion of the investigator, would make adherence to the methionine-reduced diet unsafe or impractical.
The study team makes the final eligibility decision.
Where it's taking place
- Orange, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orange, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.