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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
50
Ancillary studies
Given L-theanine PO
City of Hope Medical Center
Duarte, California, United States
RECRUITINGCity of Hope Seacliff
Huntington Beach, California, United States
NOT_YET_RECRUITINGCity of Hope at Irvine Lennar
Irvine, California, United States
NOT_YET_RECRUITINGCity of Hope at Irvine Sand Canyon
Irvine, California, United States
NOT_YET_RECRUITINGAdherence rates
Will consider the study feasible if at least 75% of enrolled participants adhere to the planned intervention. Adherence will be defined as having at least 75% study drug accountability. Will be estimated along with the 95% exact binomial confidence interval.
Time frame: Up to 8 weeks
Perceived levels of relaxation
Measured via Visual Analog Scale-Relaxation (VAS-R). Response is defined as a favorable change of at least 1.5 points on the VAS-R. Will be estimated along with the 95% exact binomial confidence interval. Within-group mean changes in VAS-R will be examined using paired t-tests (comparing any two time points of interest).
Time frame: From baseline to day 42
Self-perceived anxiety
Assessed via Visual Analog Scale-Anxiety. Within-group mean changes will be examined using paired t-tests (comparing any two time points of interest). Between-group mean changes will be evaluated at each time point using independent-samples t-tests.
Time frame: From screening to day 42
Anxiety and depression
Assessed via Hospital Anxiety and Depression Scale. Within-group mean changes will be examined using paired t-tests (comparing any two time points of interest). Between-group mean changes will be evaluated at each time point using independent-samples t-tests.
Time frame: From baseline to day 42
Transient mood states
Assessed via Short Form of the Profile of Mood States that includes tension-anxiety, depression-dejection, anger-hostility, vigor-activity, fatigue-inertia, and confusion-bewilderment. Within-group mean changes will be examined using paired t-tests (comparing any two time points of interest). Between-group mean changes will be evaluated at each time point using independent-samples t-tests.
Time frame: From baseline to day 42
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