Recruiting
Early Phase 1

L-theanine

Sponsor:

City of Hope Medical Center

Code:

NCT07220447

Conditions

Hematopoietic and Lymphatic System Neoplasm

Malignant Solid Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Survey Administration

Theanine

Study Details

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.

Conditions

Hematopoietic and Lymphatic System Neoplasm

Malignant Solid Neoplasm

Study ID

NCT07220447

Start date

Apr 21, 2026

Status verified date

May, 2026

Completion date

Jul 9, 2027

Anticipated

Primary completion date

Jul 9, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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
  • 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 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
  • 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

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Arm I (L-theanine QD)

Patients receive L-theanine PO QD for 6 weeks in the absence of unacceptable toxicity.

experimental: Arm II (L-theanine BID)

Patients receive L-theanine PO BID for 6 weeks in the absence of unacceptable toxicity.

Interventions

Survey Administration

Ancillary studies

Theanine

Given L-theanine PO

Primary outcome measure

  • Adherence rates [ Time Frame: Up to 8 weeks ]
  • Perceived levels of relaxation [ Time Frame: From baseline to day 42 ]

Central Contacts and Locations

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

Erica Veguilla

949-671-4673eveguilla@coh.org

Principal Investigator:

Erica Veguilla

More Information

Sponsor

City of Hope Medical Center

Last update posted

May 8, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2026-05-08.