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โ† Trials
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L-Theanine to Support Relaxation and Mood for Cancer Patients in Surveillance

RecruitingEARLY Phase 1Ages 18 Years - anyAllCity of Hope Medical Center
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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: โ‰ฅ 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)
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What it tests

  • Survey Administration
  • Theanine
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Where

4 sites
City of Hope Medical Center
Duarte, United States
City of Hope Seacliff
Huntington Beach, United States
City of Hope at Irvine Lennar
Irvine, United States
City of Hope at Irvine Sand Canyon
Irvine, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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