Status:
NOT_YET_RECRUITING
L-Theanine to Support Relaxation and Mood for Cancer Patients in Surveillance
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Hematopoietic and Lymphatic System Neoplasm
Malignant Solid Neoplasm
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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 l...
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 supp...
Eligibility Criteria
Inclusion
- 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
- 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)
Exclusion
- 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)
Key Trial Info
Start Date :
December 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 18 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT07220447
Start Date
December 21 2025
End Date
June 18 2026
Last Update
October 24 2025
Active Locations (4)
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1
City of Hope Medical Center
Duarte, California, United States, 91010
2
City of Hope Seacliff
Huntington Beach, California, United States, 92648
3
City of Hope at Irvine Lennar
Irvine, California, United States, 92618
4
City of Hope at Irvine Sand Canyon
Irvine, California, United States, 92618