AdenocarcinomaEarly Phase 1NCT07628634
Feasibility Study on the Effect of a Methionine-Reduced Diet on Serum Levels in Pts w/ Solid Tumors
A Early Phase 1 study testing Methionine-Reduced Diet in people with Adenocarcinoma and Basal Cell Carcinoma, run by University of California, Irvine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma, Basal Cell Carcinoma, Squamous Cell Carcinoma
- What is being tested?
- Methionine-Reduced Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2026to 1 May 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chao Family Comprehensive Cancer Center University of California, Irvine contact
University of California Irvine Medical contact
United States1 site, 1 recruiting
- Recruiting
Chao Family Comprehensive Cancer Center, University of California, Irvine
Orange, California, 92868
Zhaohui A Arter, MD, 877-827-8839, ucstudy@uci.edu
About this study
Official title: 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.
- Conditions
- Adenocarcinoma, Basal Cell Carcinoma, Squamous Cell Carcinoma, Transitional Cell Carcinoma, Ductal Carcinoma, Osteosarcoma
- Being tested
- Methionine-Reduced Diet
- Medical subject headings
- Adenocarcinoma, Carcinoma, Basal Cell, Carcinoma, Squamous Cell, Carcinoma, Transitional Cell, Carcinoma, Ductal, Osteosarcoma, Sarcoma, Sarcoma, Ewing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methionine-Reduced DietOther
Normal diet days 1-3 and 8, Methionine-Reduced Diet days 4-7, standard of care cancer treatment initiation on day 8.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm: Methionine-Reduced Diet | Experimental | Not described Receives: Other: Methionine-Reduced Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Patient Adherence to Diet
Describe the feasibility of patients' ability to adhere to a methionine-reduced diet
Measured: 8 days
Secondary outcomes (3)
Safety and Tolerability of Diet
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
Measured: 43 days
Correlative Biomarker changes
measure changes in serum methionine levels
Measured: 43 days
Change in Quality of Life
Changes in quality of life during intervention per EORTC QLQ-C30 questionnaire.
Measured: 8 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start1 May 2026
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaohui Liao Arter, University of California, Irvine
- Investigators
- Zhaohui A Arter, MD, Principal investigator, Chao Family Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07628634
- Sponsor's protocol ID
- STUDY00000464
- Other IDs
- UCI 24-87
- Status last verified
- Jul 2026
- First submitted
- 20 May 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study on the Effect of a Methionine-Reduced Diet on Serum Levels in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT07628634
- Acronym / sponsor ID
- STUDY00000464
- Conditions
- Adenocarcinoma, Basal Cell Carcinoma, Squamous Cell Carcinoma, Transitional Cell Carcinoma, Ductal Carcinoma, Osteosarcoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm: Methionine-Reduced Diet | Experimental | Other: Methionine-Reduced Diet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methionine-Reduced DietNormal diet days 1-3 and 8, Methionine-Reduced Diet days 4-7, standard of care cancer treatment initiation on day 8. | Other | Single Arm: Methionine-Reduced Diet |
Primary outcome
Feasibility of Patient Adherence to Diet
Time frame: 8 days
Describe the feasibility of patients' ability to adhere to a methionine-reduced diet
3 secondary outcomes
Safety and Tolerability of Diet
Time frame: 43 days
Correlative Biomarker changes
Time frame: 43 days
Change in Quality of Life
Time frame: 8 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chao Family Comprehensive Cancer Center University of California, Irvine contact
University of California Irvine Medical contact
Zhaohui A Arter, MD principal investigator
Chao Family Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Methionine-Reduced Diet in people with Adenocarcinoma and Basal Cell Carcinoma, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chao Family Comprehensive Cancer Center University of California, Irvine (877-827-8839, ucstudy@uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Patient Adherence to Diet (time frame: 8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.