RecruitingEarly Phase 1NCT07220447

L-Theanine to Support Relaxation and Mood for Cancer Patients in Surveillance

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

Sponsor

City of Hope Medical Center

Enrollment

50 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

Hematopoietic and Lymphatic System Neoplasm Malignant Solid Neoplasm

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. It works by increasing certain chemicals within the body that have been associated with stress reduction, mood stabilization, and improved cognitive performance.

Eligibility

Min Age: 18 Years

Inclusion Criteria12

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 Criteria11

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)