L-Theanine to Support Relaxation and Mood for Cancer Patients in Surveillance
Start Date
4/21/2026
Completion Date
7/9/2027
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.
Detailed Description
PRIMARY OBJECTIVES: I. To determine the feasibility of L-theanine use among cancer patients in surveillance based on adherence. II. To determine the relationship of L-theanine on relaxation and supporting mood among cancer patients in surveillance with a dose of 200mg once daily versus (vs) twice daily, as measured by Visual Analog Scale-Relaxation (VAS-R). SECONDARY OBJECTIVES: I. To observe the relationship of L-theanine in reducing anxiety among cancer patients in surveillance, as measured by Visual Analog Scale-Anxiety (VAS-A). II. To observe the relationship of L-theanine on mood states as measured by Short Form of the Profile of Mood States (POMS-SF). EXPLORATORY OBJECTIVES: I. To determine the feasibility of L-theanine use among cancer patients in surveillance based on recruitment. II. To observe the relationship of L-theanine in supporting sleep among cancer patients in surveillance as measured by the Pittsburgh Sleep Quality Index (PSQI). III. To describe the side effects of L-theanine supplementation. IV. To observe the relationship between L-theanine on symptom burden among cancer patients in surveillance as measured by Edmonton Symptom Assessment Scale (ESAS). OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive L-theanine orally (PO) once daily (QD) for 6 weeks in the absence of unacceptable toxicity. ARM II: Patients receive L-theanine PO twice daily (BID) for 6 weeks in the absence of unacceptable toxicity. After completion of study intervention, patients are followed up at 14 days.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Survey Administration
Theanine
Conditions
Locations
City of Hope Medical Center
Duarte, California 91010
United States
City of Hope Seacliff
Huntington Beach, California 92648
United States
City of Hope at Irvine Lennar
Irvine, California 92618
United States
City of Hope at Irvine Sand Canyon
Irvine, California 92618
United States