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NCT07220447 | RECRUITING | Hematopoietic and Lymphatic System Neoplasm

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

City of Hope Medical Center

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.

Condition or disease

Hematopoietic and Lymphatic System Neoplasm

Malignant Solid Neoplasm

Intervention/treatment

Survey Administration

Theanine

Phase

EARLY_PHASE1

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 50 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Investigating the Feasibility and Relationship of L-Theanine in Supporting Relaxation and Mood in Cancer Patients in Surveillance
Actual Study Start Date : 2026-04-01
Estimated Primary Completion Date : 2027-07-09
Estimated Study Completion Date : 2027-07-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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)
L-Theanine to Support Relaxation and Mood for Cancer Patients in Surveillance

Location Details

NCT07220447

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

City of Hope Medical Center

Duarte, California, United States, 91010

NOT YET RECRUITING

United States, California

City of Hope Seacliff

Huntington Beach, California, United States, 92648

NOT YET RECRUITING

United States, California

City of Hope at Irvine Lennar

Irvine, California, United States, 92618

NOT YET RECRUITING

United States, California

City of Hope at Irvine Sand Canyon

Irvine, California, United States, 92618