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Clinical trial Recruiting at 1 site Early Phase 1 Interventional Ages 18 and up

L-theanine for relaxation and mood support in cancer patients on surveillance

Official title: Investigating the Feasibility and Relationship of L-Theanine in Supporting Relaxation and Mood in Cancer Patients in Surveillance

Run by City of Hope Medical Center · NCT07220447 · Data updated 2026-11-12

This trial tests whether taking 200 mg of L-theanine once or twice daily for six weeks can help relaxation and mood in adult cancer patients who have finished treatment and are in surveillance.

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Quick facts

PhaseEarly Phase 1
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment50 (estimated)
SponsorCity of Hope Medical Center
Academic / other
Drugs / interventionsChemotherapy, immunotherapy, radiation
Locations4 sites (Duarte, California and 3 other locations)
StatusRecruiting
StartedApril 21, 2026
Main results expectedJuly 9, 2027
Study endsJuly 9, 2027
Registry record updatedMay 8, 2026
Trial IDNCT07220447 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (≥18) who have completed cancer treatment and been in surveillance at least six months, report a VAS-A anxiety score >3, can read English or Spanish, have not used other supplements in the past 30 days, and have had no psychiatric medication changes in the past 60 days.

Probably not a fit

Patients currently receiving active cancer treatment, those with low baseline anxiety (VAS-A ≤3), recent herbal/supplement use, unstable psychiatric medication regimens, or pregnant women are unlikely to be eligible or to gain benefit from this intervention.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized early-phase trial enrolls adult cancer patients who have completed treatment and been in surveillance for at least six months to compare two dosing schedules of L-theanine. Participants are randomized to 200 mg L-theanine once daily or 200 mg twice daily for six weeks, with adherence, safety, and symptom questionnaires collected. Primary outcomes include feasibility measured by adherence and change in relaxation measured by the Visual Analog Scale-Relaxation (VAS-R), with secondary measures of anxiety (VAS-A) and mood (POMS-SF), and exploratory measures including sleep (PSQI), symptom burden (ESAS), and side effects. Eligibility requires baseline anxiety >3 on VAS-A, no herbal/supplement use in the prior 30 days, stable psychiatric medications for 60 days, and ability to complete questionnaires in English or Spanish.

Why it matters

Potential benefit: If successful, L-theanine could provide a low-cost, well-tolerated option to help cancer survivors feel more relaxed and improve mood and sleep.

How similar studies have gone: Small prior studies in non-cancer populations have reported modest anxiety and sleep benefits from L-theanine, but there are few randomized trials specifically in cancer survivors, so evidence is limited.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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
* 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)

Exclusion Criteria:

* 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
* 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)

Where it's running

  • City of Hope Medical Center
    Duarte, California, United States     Recruiting
  • City of Hope Seacliff
    Huntington Beach, California, United States     Not yet recruiting
  • City of Hope at Irvine Lennar
    Irvine, California, United States     Not yet recruiting
  • City of Hope at Irvine Sand Canyon
    Irvine, California, United States     Not yet recruiting

Study contacts

  • Principal investigator: Erica Veguilla — City of Hope Medical Center

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.