Recruiting

L-Theanine for Relaxation and Mood in Cancer Surveillance

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What is being tested

Survey Administration

+ Theanine

OtherDrug
Who is being recruted

Over 18 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Early Phase 1
Interventional
Study Start: April 2026
See protocol details

Summary

Principal SponsorCity of Hope Medical Center
Last updated: February 13, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2026

Actual date on which the first participant was enrolled.

This study focuses on exploring the effects of L-theanine, a compound found in tea, on relaxation and mood among cancer patients who are under surveillance but not actively undergoing treatment. The main goal is to see if taking L-theanine is practical for these patients and if it helps improve their relaxation and mood. The study aims to find out if a daily dose of 200mg once or twice can make a significant difference. This research is important because managing stress and mood can be challenging for cancer patients, and finding a simple supplement like L-theanine that might help can improve their quality of life. Participants in this study are randomly assigned to one of two groups. One group takes L-theanine orally once a day, while the other takes it twice a day, for a period of six weeks. Researchers use various scales to measure changes in relaxation, anxiety, and mood, such as the Visual Analog Scale and the Profile of Mood States. They also look at sleep quality and any side effects that might occur. After the six-week period, participants have a follow-up check 14 days later to assess any ongoing effects or changes. The study also assesses how easy it is to recruit and keep participants engaged throughout the trial.

Official TitleInvestigating the Feasibility and Relationship of L-Theanine in Supporting Relaxation and Mood in Cancer Patients in Surveillance
NCT07220447
Principal SponsorCity of Hope Medical Center
Last updated: February 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

6 inclusion criteria required to participate
Willingness to comply with all study interventions including the use of L-theanine and follow-up assessments

Ability to read and understand English or Spanish for questionnaires

Participants must not have used any herbs or supplements in the past 30 days

Participants must not have had any changes to their psychiatric medications within the past 60 days

Show More Criteria

4 exclusion criteria prevent from participating
Females only: Pregnant or breastfeeding

Any patients taking bortezomib, as L-theanine can decrease effectiveness

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

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Recruiting

City of Hope Medical Center

Duarte, United StatesOpen City of Hope Medical Center in Google Maps
Recruiting soon

City of Hope Seacliff

Huntington Beach, United States
Recruiting soon

City of Hope at Irvine Lennar

Irvine, United States
Recruiting soon

City of Hope at Irvine Sand Canyon

Irvine, United States
Recruiting
4 Study Centers