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

Inclusion Criteria:

• Documented informed consent of the participant and/or legally authorizedrepresentative.

• Assent, when appropriate, will be obtained per institutional guidelines

• Willingness to comply with all study interventions including the use of L-theanineand 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 insurveillance 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 withinthe past 60 days

• Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. Ifthe urine test is positive or cannot be confirmed as negative, a serum pregnancytest will be required

• Agreement by females and males of childbearing potential to use an effective methodof birth control or abstain from heterosexual activity for the course of the studythrough at least 1 month after the last dose of protocol therapy.

• Childbearing potential defined as not being surgically sterilized (men andwomen) 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-dosevitamins and minerals, unless taken to correct a documented vitamin or mineralinsufficiency

• Chemotherapy, radiation therapy, biological therapy, immunotherapy, or any othersystemic treatment excluding hormonal therapy (must be on a stable dose of hormonaltherapy 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 withthe results of this study

• History of allergic reactions attributed to compounds of similar chemical orbiologic composition to study agent

• Any patients with an ongoing active/unstable psychiatric condition,depressive/bi-polar related disorders, anxiety, psychosis disorders, or substanceuse that may interfere with the ability to participate in the study as outlined inthe 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 thepatient's participation in the clinical study due to safety concerns with clinicalstudy procedures

• Prospective participants who, in the opinion of the investigator, may not be able tocomply with all study procedures (including compliance issues related tofeasibility/logistics)