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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-05686 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 24886 | Other Identifier | City of Hope Medical Center | |
| P30CA033572 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (L-theanine QD) | Experimental | Patients receive L-theanine PO QD for 6 weeks in the absence of unacceptable toxicity. |
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| Arm II (L-theanine BID) | Experimental | Patients receive L-theanine PO BID for 6 weeks in the absence of unacceptable toxicity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Survey Administration | Other | Ancillary studies |
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| Measure | Description | Time Frame |
|---|---|---|
| Adherence 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. | 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). | From baseline to day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From screening to day 42 |
| Anxiety and depression |
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Inclusion Criteria:
Documented informed consent of the participant and/or legally authorized representative.
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erica Veguilla | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Recruiting | Duarte | California | 91010 | United States |
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| ID | Term |
|---|---|
| C026166 | theanine |
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| Theanine | Drug | Given L-theanine PO |
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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. |
| 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. | From baseline to day 42 |
| City of Hope Seacliff | Not yet recruiting | Huntington Beach | California | 92648 | United States |
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| City of Hope at Irvine Lennar | Not yet recruiting | Irvine | California | 92618 | United States |
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| City of Hope at Irvine Sand Canyon | Not yet recruiting | Irvine | California | 92618 | United States |
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