L-Theanine to Support Relaxation and Mood for Cancer Patients in Surveillance
- Conditions
- Hematopoietic and Lymphatic System NeoplasmMalignant Solid Neoplasm
- Interventions
- Other: Survey Administration
- Registration Number
- NCT07220447
- Lead Sponsor
- City of Hope Medical Center
- Brief 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 50
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Documented informed consent of the participant and/or legally authorized representative.
- Assent, when appropriate, will be obtained per institutional guidelines
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Willingness to comply with all study interventions including the use of L-theanine and follow-up assessments
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Age: ≥ 18 years
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Ability to read and understand English or Spanish for questionnaires
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Patients must be a cancer patient who has completed treatment and has been in surveillance for at least 6 months
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Participants must not have used any herbs or supplements in the past 30 days
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Participants must report an anxiety score of > 3 on Visual Analog Scale - Anxiety
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Participants must not have had any changes to their psychiatric medications within the past 60 days
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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
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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)
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm I (L-theanine QD) Survey Administration Patients receive L-theanine PO QD for 6 weeks in the absence of unacceptable toxicity. Arm I (L-theanine QD) Theanine Patients receive L-theanine PO QD for 6 weeks in the absence of unacceptable toxicity. Arm II (L-theanine BID) Survey Administration Patients receive L-theanine PO BID for 6 weeks in the absence of unacceptable toxicity. Arm II (L-theanine BID) Theanine Patients receive L-theanine PO BID for 6 weeks in the absence of unacceptable toxicity.
- Primary Outcome Measures
Name Time Method Adherence rates Up to 8 weeks 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.
Perceived levels of relaxation From baseline to day 42 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).
- Secondary Outcome Measures
Name Time Method Self-perceived anxiety From screening to day 42 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.
Anxiety and depression From baseline to day 42 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.
Transient mood states From baseline to day 42 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.
Trial Locations
- Locations (4)
City of Hope Medical Center
🇺🇸Duarte, California, United States
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
City of Hope Medical Center🇺🇸Duarte, California, United StatesErica VeguillaPrincipal Investigator