Hematopoietic and Lymphatic System NeoplasmEarly Phase 1NCT07220447
L-Theanine to Support Relaxation and Mood for Cancer Patients in Surveillance
A Early Phase 1 study testing Survey Administration and Theanine in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by City of Hope Medical Center at 4 sites in United States.
Trial summary
This clinical trial tests the feasibility, best dose, and effectiveness of L-theanine for supporting relaxation and mood among cancer patients in surveillance. L-theanine is a substance found in the leaves of green tea with potential to enhance mental health and well-being. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Survey Administration and Theanine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 4 sitesUnited States
- Study dates
- 21 Apr 2026to 9 Jul 2027
- 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
- Documented informed consent of the participant and/or legally authorized representative.
- Assent, when appropriate, will be obtained per institutional guidelines
- Willingness to comply with all study interventions including the use of L-theanine and follow-up assessments
- Age: ≥ 18 years
- Ability to read and understand English or Spanish for questionnaires
- Patients must be a cancer patient who has completed treatment and has been in surveillance for at least 6 months
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- Participants must not have used any herbs or supplements in the past 30 days
- Participants must report an anxiety score of > 3 on Visual Analog Scale - Anxiety
- Participants must not have had any changes to their psychiatric medications within the past 60 days
- Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
- Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 1 month after the last dose of protocol therapy.
- Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only)
Who cannot join
- Concurrent use of other alternative medicines, including herbal agents and high-dose vitamins and minerals, unless taken to correct a documented vitamin or mineral insufficiency
- Chemotherapy, radiation therapy, biological therapy, immunotherapy, or any other systemic treatment excluding hormonal therapy (must be on a stable dose of hormonal therapy for at least 60 days)
- Any patients taking bortezomib, as L-theanine can decrease effectiveness
- Any patients currently enrolled in other clinical trials that might interfere with the results of this study
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent
- Any patients with an ongoing active/unstable psychiatric condition, depressive/bi-polar related disorders, anxiety, psychosis disorders, or substance use that may interfere with the ability to participate in the study as outlined in the study procedures section of the protocol
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- Any patients with chronically unstable blood pressure or chronic low blood pressure
- Diagnosis of Gilbert's disease
- Females only: Pregnant or breastfeeding
- Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
- Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
City of Hope Medical Center
Duarte, California, 91010
Erica Veguilla, 949-671-4673, eveguilla@coh.org
Erica Veguilla
- Not yet recruiting
City of Hope Seacliff
Huntington Beach, California, 92648
Erica Veguilla, 949-671-4673, eveguilla@coh.org
Erica Veguilla
- Not yet recruiting
City of Hope at Irvine Lennar
Irvine, California, 92618
Erica Veguilla, 949-671-4673, eveguilla@coh.org
Erica Veguilla
- Not yet recruiting
City of Hope at Irvine Sand Canyon
Irvine, California, 92618
Erica Veguilla, 949-671-4673, eveguilla@coh.org
Erica Veguilla
About this study
Official title: Investigating the Feasibility and Relationship of L-Theanine in Supporting Relaxation and Mood in Cancer Patients in Surveillance
This clinical trial tests the feasibility, best dose, and effectiveness of L-theanine for supporting relaxation and mood among cancer patients in surveillance. L-theanine is a substance found in the leaves of green tea with potential to enhance mental health and well-being. It works by increasing certain chemicals within the body that have been associated with stress reduction, mood stabilization, and improved cognitive performance.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the feasibility of L-theanine use among cancer patients in surveillance based on adherence.
II. To determine the relationship of L-theanine on relaxation and supporting mood among cancer patients in surveillance with a dose of 200mg once daily versus (vs) twice daily, as measured by Visual Analog Scale-Relaxation (VAS-R).
SECONDARY OBJECTIVES:
- To observe the relationship of L-theanine in reducing anxiety among cancer patients in surveillance, as measured by Visual Analog Scale-Anxiety (VAS-A).
II. To observe the relationship of L-theanine on mood states as measured by Short Form of the Profile of Mood States (POMS-SF).
EXPLORATORY OBJECTIVES:
- To determine the feasibility of L-theanine use among cancer patients in surveillance based on recruitment.
II. To observe the relationship of L-theanine in supporting sleep among cancer patients in surveillance as measured by the Pittsburgh Sleep Quality Index (PSQI).
III. To describe the side effects of L-theanine supplementation. IV. To observe the relationship between L-theanine on symptom burden among cancer patients in surveillance as measured by Edmonton Symptom Assessment Scale (ESAS).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive L-theanine orally (PO) once daily (QD) for 6 weeks in the absence of unacceptable toxicity.
ARM II: Patients receive L-theanine PO twice daily (BID) for 6 weeks in the absence of unacceptable toxicity.
After completion of study intervention, patients are followed up at 14 days.
- Being tested
- Survey Administration, Theanine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey AdministrationOther
Ancillary studies
TheanineDrug
Also called L-theanine, N-Ethyl-L-Glutamine, Suntheanine, Theanin
Given L-theanine PO
| Study group | Role | What they receive |
|---|---|---|
| Arm I (L-theanine QD) | Experimental | Patients receive L-theanine PO QD for 6 weeks in the absence of unacceptable toxicity. Receives: Other: Survey Administration; Drug: Theanine |
| Arm II (L-theanine BID) | Experimental | Patients receive L-theanine PO BID for 6 weeks in the absence of unacceptable toxicity. Receives: Other: Survey Administration; Drug: Theanine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence rates
Will consider the study feasible if at least 75% of enrolled participants adhere to the planned intervention. Adherence will be defined as having at least 75% study drug accountability. Will be estimated along with the 95% exact binomial confidence interval.
Measured: Up to 8 weeks
Perceived levels of relaxation
Measured via Visual Analog Scale-Relaxation (VAS-R). Response is defined as a favorable change of at least 1.5 points on the VAS-R. Will be estimated along with the 95% exact binomial confidence interval. Within-group mean changes in VAS-R will be examined using paired t-tests (comparing any two time points of interest).
Measured: From baseline to day 42
Secondary outcomes (3)
Self-perceived anxiety
Assessed via Visual Analog Scale-Anxiety. Within-group mean changes will be examined using paired t-tests (comparing any two time points of interest). Between-group mean changes will be evaluated at each time point using independent-samples t-tests.
Measured: From screening to day 42
Anxiety and depression
Assessed via Hospital Anxiety and Depression Scale. Within-group mean changes will be examined using paired t-tests (comparing any two time points of interest). Between-group mean changes will be evaluated at each time point using independent-samples t-tests.
Measured: From baseline to day 42
Transient mood states
Assessed via Short Form of the Profile of Mood States that includes tension-anxiety, depression-dejection, anger-hostility, vigor-activity, fatigue-inertia, and confusion-bewilderment. Within-group mean changes will be examined using paired t-tests (comparing any two time points of interest). Between-group mean changes will be evaluated at each time point using independent-samples t-tests.
Measured: From baseline to day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2025
- Study start21 Apr 2026
- Primary completion9 Jul 2027 (estimated)
- Study completion9 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphatic System NeoplasmStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Erica Veguilla, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07220447
- Sponsor's protocol ID
- 24886
- Other IDs
- NCI-2025-05686, 24886, P30CA033572
- Status last verified
- May 2026
- First submitted
- 21 Oct 2025
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Feasibility and Relationship of L-Theanine in Supporting Relaxation and Mood in Cancer Patients in Surveillance
- ClinicalTrials.gov ID
- NCT07220447
- Acronym / sponsor ID
- 24886
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 21 Apr 2026 (actual)
- Primary completion
- 9 Jul 2027 (estimated)
- Study completion
- 9 Jul 2027 (estimated)
- First posted
- 24 Oct 2025 (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 clinical trial tests the feasibility, best dose, and effectiveness of L-theanine for supporting relaxation and mood among cancer patients in surveillance. L-theanine is a substance found in the leaves of green tea with potential to enhance mental health and well-being. It works by increasing certain chemicals within the body that have been associated with stress reduction, mood stabilization, and improved cognitive performance.
Detailed description
PRIMARY OBJECTIVES:
- To determine the feasibility of L-theanine use among cancer patients in surveillance based on adherence.
II. To determine the relationship of L-theanine on relaxation and supporting mood among cancer patients in surveillance with a dose of 200mg once daily versus (vs) twice daily, as measured by Visual Analog Scale-Relaxation (VAS-R).
SECONDARY OBJECTIVES:
- To observe the relationship of L-theanine in reducing anxiety among cancer patients in surveillance, as measured by Visual Analog Scale-Anxiety (VAS-A).
II. To observe the relationship of L-theanine on mood states as measured by Short Form of the Profile of Mood States (POMS-SF).
EXPLORATORY OBJECTIVES:
- To determine the feasibility of L-theanine use among cancer patients in surveillance based on recruitment.
II. To observe the relationship of L-theanine in supporting sleep among cancer patients in surveillance as measured by the Pittsburgh Sleep Quality Index (PSQI).
III. To describe the side effects of L-theanine supplementation. IV. To observe the relationship between L-theanine on symptom burden among cancer patients in surveillance as measured by Edmonton Symptom Assessment Scale (ESAS).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive L-theanine orally (PO) once daily (QD) for 6 weeks in the absence of unacceptable toxicity.
ARM II: Patients receive L-theanine PO twice daily (BID) for 6 weeks in the absence of unacceptable toxicity.
After completion of study intervention, patients are followed up at 14 days.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (L-theanine QD) | Experimental | Other: Survey Administration, Drug: TheaninePatients receive L-theanine PO QD for 6 weeks in the absence of unacceptable toxicity. |
| Arm II (L-theanine BID) | Experimental | Other: Survey Administration, Drug: TheaninePatients receive L-theanine PO BID for 6 weeks in the absence of unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Documented informed consent of the participant and/or legally authorized representative.
- Willingness to comply with all study interventions including the use of L-theanine and follow-up assessments
- Age: ≥ 18 years
- Ability to read and understand English or Spanish for questionnaires
- Patients must be a cancer patient who has completed treatment and has been in surveillance for at least 6 months
Key exclusion criteria (11 listed)
- Concurrent use of other alternative medicines, including herbal agents and high-dose vitamins and minerals, unless taken to correct a documented vitamin or mineral insufficiency
- Chemotherapy, radiation therapy, biological therapy, immunotherapy, or any other systemic treatment excluding hormonal therapy (must be on a stable dose of hormonal therapy for at least 60 days)
- Any patients taking bortezomib, as L-theanine can decrease effectiveness
- Any patients currently enrolled in other clinical trials that might interfere with the results of this study
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent
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 |
|---|---|---|
| Survey AdministrationAncillary studies | Other | Arm I (L-theanine QD), Arm II (L-theanine BID) |
| TheanineAlso: L-theanine, N-Ethyl-L-Glutamine, Suntheanine, TheaninGiven L-theanine PO | Drug | Arm I (L-theanine QD), Arm II (L-theanine BID) |
Primary outcome
Adherence rates
Time frame: Up to 8 weeks
Will consider the study feasible if at least 75% of enrolled participants adhere to the planned intervention. Adherence will be defined as having at least 75% study drug accountability. Will be estimated along with the 95% exact binomial confidence interval.
Perceived levels of relaxation
Time frame: From baseline to day 42
Measured via Visual Analog Scale-Relaxation (VAS-R). Response is defined as a favorable change of at least 1.5 points on the VAS-R. Will be estimated along with the 95% exact binomial confidence interval. Within-group mean changes in VAS-R will be examined using paired t-tests (comparing any two time points of interest).
3 secondary outcomes
Self-perceived anxiety
Time frame: From screening to day 42
Anxiety and depression
Time frame: From baseline to day 42
Transient mood states
Time frame: From baseline to day 42
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 8 May 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.
Erica Veguilla principal investigator
City of Hope Medical Center
4 sites 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 Survey Administration and Theanine in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by City of Hope Medical Center at 4 sites 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 11 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 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence rates (time frame: Up to 8 weeks). The study lists 2 primary outcomes in all. 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 8 May 2026.