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

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

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.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: City of Hope Medical Center (Academic / other)
• Drugs / interventions: Chemotherapy, immunotherapy, radiation
• Locations: 4 sites (Duarte, California and 3 other locations)
• Trial ID: NCT07220447 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Duarte, California and 3 other locations

• 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

Conditions Hematopoietic and Lymphatic System Neoplasm; Malignant Solid Neoplasm