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L-Theanine to Support Relaxation and Mood for Cancer Patients in Surveillance | Clinical Trials | Clareo Health

RECRUITINGEARLY_PHASE1

L-Theanine to Support Relaxation and Mood for Cancer Patients in Surveillance

Investigating the Feasibility and Relationship of L-Theanine in Supporting Relaxation and Mood in Cancer Patients in Surveillance

NCT07220447•City of Hope Medical Center

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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
+2 more criteria

Exclusion Criteria

•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
+1 more criteria

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

Key Dates

Start Date

April 1, 2026

Primary Completion Date

July 9, 2027

Completion Date

July 9, 2027

Last Updated

February 12, 2026

Enrollment

ESTIMATED participants

Conditions

Hematopoietic and Lymphatic System NeoplasmMalignant Solid Neoplasm

Interventions

Survey Administration

OTHER

Theanine

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

L-Theanine to Support Relaxation and Mood for Cancer Patients in Surveillance

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors

Personalized Antibody-Drug Conjugate Therapy Based on RNA and Protein Testing for the Treatment of Advanced or Metastatic Solid Tumors (The ADC MATCH Screening and Treatment Trial)

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial