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

NCT07220447 | Recruiting Early Phase 1 DMC FDA Drug

• 3 other identifiers: 24886NCI-2025-05686P30CA033572
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 4

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

Malignant Solid Neoplasm; Hematopoietic and Lymphatic System Neoplasm

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• Self-perceived anxiety

  From screening to day 42

• Anxiety and depression

  From baseline to day 42

• Transient mood states

  From baseline to day 42

Study Arms (2)

Arm I (L-theanine QD)

EXPERIMENTAL

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

Other: Survey Administration; Drug: Theanine

Arm II (L-theanine BID)

EXPERIMENTAL

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

Other: Survey Administration; Drug: Theanine

Interventions

Survey Administration OTHER

Ancillary studies

Arm I (L-theanine QD); Arm II (L-theanine BID)

Theanine DRUG

Given L-theanine PO

Also known as: L-theanine, N-Ethyl-L-Glutamine, Suntheanine, Theanin

Arm I (L-theanine QD); Arm II (L-theanine BID)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• City of Hope Medical Center: lead

Study Sites (4)

City of Hope Medical Center

Duarte, California, 91010, United States

RECRUITING

City of Hope Seacliff

Huntington Beach, California, 92648, United States

NOT YET RECRUITING

City of Hope at Irvine Lennar

Irvine, California, 92618, United States

NOT YET RECRUITING

City of Hope at Irvine Sand Canyon

Irvine, California, 92618, United States

NOT YET RECRUITING

MeSH Terms

Interventions

theanine

Study Officials

• Erica Veguilla

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2025
• First Posted: October 24, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): July 9, 2027
• Study Completion (Estimated): July 9, 2027
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

US (4)