L-Theanine to Support Relaxation and Mood for Cancer Patients in Surveillance
Recruiting now · Early Phase 1
Conditions studied: Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
In brief
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.
Key facts
- Study ID
- NCT07220447
- Run by
- City of Hope Medical Center
- People needed
- 50
- Starts
- 2026-04-21
- Expected to finish
- 2027-07-09
- Last updated by the study team
- 2026-05-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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 is running
- City of Hope Medical Center — Duarte, California, United States (enrolling)
- City of Hope Seacliff — Huntington Beach, California, United States
- City of Hope at Irvine Lennar — Irvine, California, United States
- City of Hope at Irvine Sand Canyon — Irvine, California, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.